PMA P100010S122
- Device
- Arctic Front Advance, Arctic Front Advance Pro
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S122
- Product code
- OAE
- Decision date
- 2021-12-14
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.9.
Current openFDA PMA Record#
- Device
- Arctic Front Advance, Arctic Front Advance Pro
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S122
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-12-14
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.9.