Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Classe d’instrument 3 · Comité d’examen CV
Dossier de supplément de PMA de la FDA
P130026/S045
Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE)
Supplément S045 à l’approbation préalable à la mise en marché P130026. Code de produit OAE. Décision du 7 mai 2019.
Approbation
Chaque ligne est un champ du dossier openFDA. Le nom en gris est le nom du champ dans la documentation d’openFDA (en anglais).
| Champ | Valeur | Nom du champ |
|---|---|---|
| Numéro de PMA | P130026 | pma_number |
| Numéro de supplément | S045 | supplement_number |
| Demandeur | St Jude Medical | applicant |
| Nom commercial | Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE) | trade_name |
| Nom générique | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | generic_name |
| Code de produit | OAE | product_code |
| Comité consultatif | Cardiovascular | advisory_committee_description |
| Date de réception | 2019-04-26 | date_received |
| Date de la décision | 2019-05-07 | decision_date |
| Code de décision | OK30 | decision_code |
| Type de supplément | 30-Day Notice | supplement_type |
| Motif du supplément | Process Change - Manufacturer/Sterilizer/Packager/Supplier | supplement_reason |
Source : openFDA de la FDA, device/pma, P130026/S045, récupéré le 2026-10-16 02:28 heure de l’Est. Domaine public (CC0).
Code de produit
Le dossier de classification de la FDA pour le code de ce dossier.
Vocabulaire d’ArrHub
Électrophysiologie
OAE est l’un des 61 codes de produit du vocabulaire d’électrophysiologie d’ArrHub, chacun tenu avec son dossier de classification de la FDA pour référence. Entrée de vocabulaire vérifiée le 20 septembre 2026.
Historique des suppléments
Chaque dossier de ce numéro de PMA dans la vue vérifiée d’ArrHub, du plus récent au plus ancien. Les avis courants sont listés, jamais résumés.
| Dossier | Type | Motif | Décision |
|---|---|---|---|
| P130026 FDA | approbation initiale | vide | 2014-10-24 |
| P130026/S102 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-08-07 |
| P130026/S100 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-05 |
| P130026/S101 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-29 |
| P130026/S099 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-15 |
| P130026/S098 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-15 |
| P130026/S097 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-08 |
| P130026/S096 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2025-12-23 |
| P130026/S094 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2025-06-20 |
| P130026/S095 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-05-06 |
| P130026/S093 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-04-10 |
| P130026/S092 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-27 |
| P130026/S091 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-22 |
| P130026/S090 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-10-09 |
| P130026/S089 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-21 |
| P130026/S086 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2023-11-29 |
| P130026/S088 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-10-26 |
| P130026/S087 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-08-17 |
| P130026/S084 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2023-06-29 |
| P130026/S085 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-05-02 |
| P130026/S083 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-17 |
| P130026/S082 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-15 |
| P130026/S081 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-08 |
| P130026/S080 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-10-28 |
| P130026/S079 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-08-31 |
| P130026/S077 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2022-08-17 |
| P130026/S078 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-04-27 |
| P130026/S072 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-03-04 |
| P130026/S070 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2021-11-04 |
| P130026/S076 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-10-14 |
| P130026/S075 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-22 |
| P130026/S069 FDA | Normal 180 Day Track No User Fee | Labeling Change - PAS | 2021-08-03 |
| P130026/S074 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-06-25 |
| P130026/S073 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-21 |
| P130026/S071 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-18 |
| P130026/S068 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-03-12 |
| P130026/S066 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2021-01-10 |
| P130026/S063 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-01-10 |
| P130026/S067 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-18 |
| P130026/S062 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-11-02 |
| P130026/S065 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-10-16 |
| P130026/S064 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-08-25 |
| P130026/S058 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-06-05 |
| P130026/S061 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-04 |
| P130026/S060 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-28 |
| P130026/S059 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P130026/S056 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-06 |
| P130026/S057 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-27 |
| P130026/S055 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-01-14 |
| P130026/S054 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-12-16 |
| P130026/S052 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-25 |
| P130026/S053 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-22 |
| P130026/S051 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-10-09 |
| P130026/S050 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-09-18 |
| P130026/S048 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-22 |
| P130026/S049 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-07-24 |
| P130026/S047 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-06-19 |
| P130026/S046 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-13 |
| P130026/S045 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-07 |
| P130026/S044 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-23 |
| P130026/S043 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-10 |
| P130026/S040 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-14 |
| P130026/S042 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-05 |
| P130026/S041 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-02-25 |
| P130026/S039 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-02-15 |
| P130026/S038 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-02-11 |
| P130026/S037 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-01-10 |
Source : openFDA de la FDA, device/pma, dossiers de P130026, récupérés le 2026-10-16 02:28 heure de l’Est. 67 dossiers dans la vue vérifiée. Chaque identifiant renvoie à la page de la FDA.
ArrHub
Ce qu’ArrHub ajoute au dossier. Tout ce qui précède cette ligne appartient à l’organisme ; tout ce qui suit est d’ArrHub, daté et attribué.
Dossier apparié
Aucun appariement confirmé entre les deux registres pour ce dossier.
Rattaché à
Abbott
Le nom du registre ci-dessus est rattaché à son organisation selon la table d’alias d’ArrHub. Méthode : manual:m&a. Source : fda_applicant. Vérifié le 20 septembre 2026.
Pas encore dans l’instantané hebdomadaire d’ArrHub.
Dossier brut
Le dossier stocké tel qu’ArrHub le tient, pour qui veut vérifier la page par rapport à lui.
Afficher le dossier brut (JSON)device/pma.json?search=pma_number:P130026+AND+supplement_number:S045&limit=1
{
"id": "e83d7716-6cae-471a-ab61-72f67ad9f3c6",
"pma_key": "P130026/S045",
"pma_number": "P130026",
"supplement_number": "S045",
"applicant": "St Jude Medical",
"trade_name": "Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE)",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2019-05-07",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2019-04-26",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130026&s=S045",
"verified_at": "2026-10-16T06:51:13.807+00:00",
"created_at": "2026-10-16T06:28:37.103881+00:00",
"collected_at": "2026-10-16T06:28:22.358+00:00",
"last_checked_at": "2026-10-16T06:51:13.807+00:00"
}La page lisible est rendue à partir du dossier tenu dans la vue vérifiée d’ArrHub ; le dossier de l’organisme à api.fda.gov fait foi en cas de divergence.
Les liens ouvrent les dossiers propres à l’organisme. Les liens sans étiquette ouvrent des pages web. Les liens marqués (JSON) ouvrent un dossier de données d’un organisme, qu’un navigateur affiche en texte brut.
Signalez un lien brisé ou une inscription qui ne correspond pas à sa source : alerts@arrhub.com. Les corrections sont publiées, avec leur date, à arrhub.com/corrections.
© 2026 ArrHub. Contenu mis à disposition sous licence.