Arctic Front Advance™ Cardiac Cryoablation Catheter, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter

Supplément S140 à l’approbation préalable à la mise en marché P100010. Code de produit OAE. Décision du 19 septembre 2023.

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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	P100010	pma_number
Numéro de supplément	S140	supplement_number
Demandeur	Medtronic Cryocath, LP	applicant
Nom commercial	Arctic Front Advance™ Cardiac Cryoablation Catheter, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter	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	2023-08-25	date_received
Date de la décision	2023-09-19	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/S140, 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
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:S140&limit=1

{
  "id": "401bdd89-5aa8-4db0-a623-a0f353518efc",
  "pma_key": "P100010/S140",
  "pma_number": "P100010",
  "supplement_number": "S140",
  "applicant": "Medtronic Cryocath, LP",
  "trade_name": "Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter",
  "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
  "product_code": "OAE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2023-09-19",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2023-08-25",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100010&s=S140",
  "verified_at": "2026-10-16T06:50:32.489+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": "2026-10-16T06:50:32.489+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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