PMA P100010S085
- Device
- Arctic Front Advance Cardiac CryoAblation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S085
- Product code
- OAE
- Decision date
- 2018-09-25
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- New inspection of Guide Wire Lumen subassemblies, used in the manufacturing of Arctic Front Advance (Models 2AF234 and 2AF284) catheters.
Current openFDA PMA Record#
- Device
- Arctic Front Advance Cardiac CryoAblation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S085
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-09-25
- Decision code
- OK30
- Date received
- 2018-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New inspection of Guide Wire Lumen subassemblies, used in the manufacturing of Arctic Front Advance (Models 2AF234 and 2AF284) catheters.