Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter
FDA premarket approval P100010/S111 · decided 2020-12-15
Approval details
- PMA number
- P100010
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic Cryocath, LP
- Date received
- 2020-11-19
- Decision date
- 2020-12-15
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- to implement two alternate manufacturing Cell Operating System (COS) stations and to update associated equipment and inspection procedures
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 |