PMA P100010S088
- Device
- Arctic Front Advance Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S088
- Product code
- OAE
- Decision date
- 2019-03-05
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Addition of a manufacturing line (duplicating existing manufacturing line A7 using an identical manufacturing process) at your firm’s Montreal Manufacturing Facility (MMO).
Current openFDA PMA Record#
- Device
- Arctic Front Advance Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S088
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-03-05
- Decision code
- OK30
- Date received
- 2019-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a manufacturing line (duplicating existing manufacturing line A7 using an identical manufacturing process) at your firm’s Montreal Manufacturing Facility (MMO).