PMA P100010S001
- Device
- ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S001
- Product code
- OAE
- Decision date
- 2011-08-23
- 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 OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S001
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2011-08-23
- Decision code
- APPR
- Date received
- 2011-01-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.