PMA P100010S102
- Device
- Artic Front Advance Pro Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S102
- Product code
- OAE
- Decision date
- 2020-03-05
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Re-sequence the manufacturing procedures at station P13.
Current openFDA PMA Record#
- Device
- Artic Front Advance Pro Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S102
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-03-05
- Decision code
- OK30
- Date received
- 2020-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Re-sequence the manufacturing procedures at station P13.