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
P100010/S136
Manual Retraction Kit
Supplément S136 à l’approbation préalable à la mise en marché P100010. Code de produit OAE. Décision du 28 février 2023.
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 | P100010 | pma_number |
| Numéro de supplément | S136 | supplement_number |
| Demandeur | Medtronic Cryocath, LP | applicant |
| Nom commercial | Manual Retraction Kit | 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 | 2023-01-30 | date_received |
| Date de la décision | 2023-02-28 | 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, P100010/S136, 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 |
|---|---|---|---|
| P100010 FDA | approbation initiale | vide | 2010-12-17 |
| P100010/S154 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-09-25 |
| P100010/S152 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-08-06 |
| P100010/S153 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-04-23 |
| P100010/S150 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-27 |
| P100010/S151 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-18 |
| P100010/S149 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-13 |
| P100010/S148 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-03 |
| P100010/S147 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-06-07 |
| P100010/S145 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-29 |
| P100010/S146 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-26 |
| P100010/S141 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2024-03-25 |
| P100010/S144 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-01-08 |
| P100010/S143 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-11-29 |
| P100010/S142 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-10-06 |
| P100010/S140 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-09-19 |
| P100010/S139 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2023-08-21 |
| P100010/S138 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-01 |
| P100010/S131 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-27 |
| P100010/S137 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-06 |
| P100010/S136 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-02-28 |
| P100010/S135 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-01-19 |
| P100010/S134 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-01-19 |
| P100010/S133 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-07 |
| P100010/S132 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-11-09 |
| P100010/S130 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-23 |
| P100010/S129 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-08-24 |
| P100010/S128 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-06-01 |
| P100010/S127 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-05-06 |
| P100010/S125 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-03-16 |
| P100010/S126 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-03-15 |
| P100010/S123 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2022-03-07 |
| P100010/S124 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-01-20 |
| P100010/S118 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-12-16 |
| P100010/S122 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-12-14 |
| P100010/S121 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-11-17 |
| P100010/S120 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-11-09 |
| P100010/S119 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-11-05 |
| P100010/S117 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-10 |
| P100010/S116 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-08-06 |
| P100010/S110 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2021-06-18 |
| P100010/S114 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-06-10 |
| P100010/S115 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-13 |
| P100010/S113 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-03 |
| P100010/S108 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-02-11 |
| P100010/S112 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-15 |
| P100010/S111 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-15 |
| P100010/S109 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-11-09 |
| P100010/S107 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-08-13 |
| P100010/S106 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-25 |
| P100010/S098 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2020-06-23 |
| P100010/S105 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-18 |
| P100010/S104 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-20 |
| P100010/S102 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-05 |
| P100010/S103 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-24 |
| P100010/S101 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-03 |
| P100010/S100 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-01-17 |
| P100010/S099 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-12-10 |
| P100010/S097 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-18 |
| P100010/S096 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-09-19 |
| P100010/S093 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-27 |
| P100010/S095 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-06-17 |
| P100010/S094 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-06-04 |
| P100010/S090 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-29 |
| P100010/S092 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-08 |
| P100010/S091 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-03 |
| P100010/S086 FDA | Normal 180 Day Track No User Fee | Labeling Change - Indications/instructions/shelf life/tradename | 2019-05-01 |
| P100010/S089 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-03 |
| P100010/S088 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-05 |
| P100010/S087 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-01-03 |
Source : openFDA de la FDA, device/pma, dossiers de P100010, récupérés le 2026-10-16 02:28 heure de l’Est. 70 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
Medtronic
Le nom du registre ci-dessus est rattaché à son organisation selon la table d’alias d’ArrHub. Méthode : manual. 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:P100010+AND+supplement_number:S136&limit=1
{
"id": "77d81e1f-efba-4051-8a94-561a90f29654",
"pma_key": "P100010/S136",
"pma_number": "P100010",
"supplement_number": "S136",
"applicant": "Medtronic Cryocath, LP",
"trade_name": "Manual Retraction Kit",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2023-02-28",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2023-01-30",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100010&s=S136",
"verified_at": "2026-10-16T06:50:29.824+00:00",
"created_at": "2026-10-16T06:28:37.266536+00:00",
"collected_at": "2026-10-16T06:28:22.358+00:00",
"last_checked_at": "2026-10-16T06:50:29.824+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.
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