PMA P100010S093
- Device
- Artic Front Advance Pro Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S093
- Product code
- OAE
- Decision date
- 2019-06-27
- 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 catheter check valve material change.
Current openFDA PMA Record#
- Device
- Artic Front Advance Pro Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S093
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-06-27
- Decision code
- APPR
- Date received
- 2019-05-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a catheter check valve material change.