- Device
- Arctic Front Advance® Cardiac CryoAblation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S134
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2023-01-19
- Decision code
- OK30
- Date received
- 2022-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an alternative to the batch endotoxin monitoring program at the Montreal Medtronic Operations (MMO) manufacturing site in Canada.