PMA P100010S115
- Device
- Arctic Front Advance Cardiac CryoAblation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S115
- Product code
- OAE
- Decision date
- 2021-05-13
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Additional manufacturing line at the Villalba, Puerto Rico site.
Current openFDA PMA Record#
- Device
- Arctic Front Advance Cardiac CryoAblation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S115
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-05-13
- Decision code
- OK30
- Date received
- 2021-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional manufacturing line at the Villalba, Puerto Rico site.