- Device
- Arctic Front Advance and Arctic Front Pro Catheters Shaft Components
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S109
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-11-09
- Decision code
- OK30
- Date received
- 2020-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the catheter shaft component manufacturing site and add a new laser to the catheter manufacturing process.