7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM
FDA premarket approval P020045/S010 · decided 2005-09-02
Approval details
- PMA number
- P020045
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic Cryocath, LP
- Date received
- 2005-06-16
- Decision date
- 2005-09-02
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE STOP BUTTON ON THE CRYOCONSOLE FROM THE CURRENT SIZE OF 19 MM TO THE PROPOSED 16 MM SIZE STOP BUTTON.
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 |