TactiSys™ Quartz Equipment

Supplément S078 à l’approbation préalable à la mise en marché P130026. Code de produit OAE. Décision du 27 avril 2022.

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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	S078	supplement_number
Demandeur	St Jude Medical	applicant
Nom commercial	TactiSys™ Quartz Equipment	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	2022-01-27	date_received
Date de la décision	2022-04-27	decision_date
Code de décision	APPR	decision_code
Type de supplément	Real-Time Process	supplement_type
Motif du supplément	Process Change - Manufacturer/Sterilizer/Packager/Supplier	supplement_reason

Source : openFDA de la FDA, device/pma, P130026/S078, 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.

OAE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

Classe d’instrument 3 · Comité d’examen CV

Tous les dossiers portant ce codeDossier de classification sur la FDA

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:S078&limit=1

{
  "id": "96ca4b12-9a10-4f51-8c0c-621f13cf4648",
  "pma_key": "P130026/S078",
  "pma_number": "P130026",
  "supplement_number": "S078",
  "applicant": "St Jude Medical",
  "trade_name": "TactiSys Quartz Equipment",
  "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
  "product_code": "OAE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2022-04-27",
  "decision_code": "APPR",
  "supplement_type": "Real-Time Process",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2022-01-27",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130026&s=S078",
  "verified_at": "2026-10-16T06:51:32.753+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": "2026-10-16T06:51:32.753+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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