PMA P100010S128
- Device
- Arctic Front Advance, Arctic Front Advance Pro
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S128
- Product code
- OAE
- Decision date
- 2022-06-01
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Update the FACTORYWorks Manufacturing Execution System to Release 9.10.
Current openFDA PMA Record#
- Device
- Arctic Front Advance, Arctic Front Advance Pro
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S128
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-06-01
- Decision code
- OK30
- Date received
- 2022-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the FACTORYWorks Manufacturing Execution System to Release 9.10.