ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
FDA premarket approval P100010/S015 · decided 2012-04-12
Approval details
- PMA number
- P100010
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic Cryocath, LP
- Date received
- 2012-02-17
- Decision date
- 2012-04-12
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CATHETER CHANGES TO INCREASE THE UNIFORMITY OF THE DISTAL BALLOON SURFACE TEMPERATURE (INCREASED NUMBER OF REFRIGERANT PORTS ON THE INJECTION TUBE COIL, MORE DISTAL POSITION OF THE INJECTION TUBE, INCREASED REFRIGERANT FLOW ON THE 28MM BALLOON), TO ADD NEW VISUAL MARKER ON THE CATHETER SHAFT AND TO IMPLEMENT ADDITIONAL MINOR CHANGES TO THE DESIGN AND LABELING.
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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 |