PMA P100010S097
- Device
- Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S097
- Product code
- OAE
- Decision date
- 2019-10-18
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Equipment and process changes for manufacturing the balloon assembly of the Arctic Front Advance and Arctic Front Advance Pro Cryoablation catheters.
Current openFDA PMA Record#
- Device
- Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S097
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-10-18
- Decision code
- OK30
- Date received
- 2019-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Equipment and process changes for manufacturing the balloon assembly of the Arctic Front Advance and Arctic Front Advance Pro Cryoablation catheters.