PMA P100010S084
- Device
- Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S084
- Product code
- OAE
- Decision date
- 2018-11-09
- 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 design, manufacturing and product requirement changes to the Luer component of the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters.
Current openFDA PMA Record#
- Device
- Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S084
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-11-09
- Decision code
- APPR
- Date received
- 2018-09-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design, manufacturing and product requirement changes to the Luer component of the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters.