PMA P100010S154
- Device
- STOP Persistent AF
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S154
- Product code
- OAE
- Decision date
- 2026-09-25
- Classification
- Cardiovascular
- 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.
Current openFDA PMA Record#
- Device
- STOP Persistent AF
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S154
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-09-25
- Decision code
- APPR
- Date received
- 2026-02-27
- 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.