PMA P100010

Device: Stop AF First
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S134
Product code: OAE
Decision date: 2026-08-06
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: approval of the early termination for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P100010/S110.

Current openFDA PMA Record#

Device: Stop AF First
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S152
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2026-08-06
Decision code: APPR
Date received: 2025-08-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the early termination for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P100010/S110.