Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe
FDA premarket approval P100010/S116 · decided 2021-08-06
Approval details
- PMA number
- P100010
- Supplement
- S116
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic Cryocath, LP
- Date received
- 2021-07-08
- Decision date
- 2021-08-06
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co., Villalba for full assembly, sterilization, packaging, and distribution.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FlexCath Advance Steerable Sheath and Dilator (K202620) | Medtronic Cryocath, LP | 2020-11-13 |
| FlexCath Advance Steerable Sheath and Dilator (K183174) | Medtronic Cryocath, LP | 2018-11-26 |
| FlexCath Select Steerable Shealth and Dilator (K163268) | Medtronic Cryocath, LP | 2017-02-02 |
| FlexCath Select Steerable Sheath (10 French) (K142684) | Medtronic Cryocath, LP | 2014-11-06 |
| FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591) | Medtronic Cryocath, LP | 2012-12-27 |
| FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 (K102176) | Medtronic Cryocath, LP | 2010-09-01 |