PMA P100010S094
- Device
- Arctic Front Advance Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S094
- Product code
- OAE
- Decision date
- 2019-06-04
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for a manufacturing site located at:Medtronic, Inc.Medtronic Puerto Rico Operations Co.Rd. 149, Km 56.3, Call Box 6001Villalba, Puerto Rico 007766 USA
Current openFDA PMA Record#
- Device
- Arctic Front Advance Cardiac Cryoablation Catheters
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S094
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-06-04
- Decision code
- APPR
- Date received
- 2019-05-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at:Medtronic, Inc.Medtronic Puerto Rico Operations Co.Rd. 149, Km 56.3, Call Box 6001Villalba, Puerto Rico 007766 USA