PMA P100010S086
- Device
- Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S086
- Product code
- OAE
- Decision date
- 2019-05-01
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for a labeling update to incorporate post-approval study data from the STOP AF Post Approval Study.
Current openFDA PMA Record#
- Device
- Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S086
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-05-01
- Decision code
- APPR
- Date received
- 2018-11-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update to incorporate post-approval study data from the STOP AF Post Approval Study.