CardioGenesis TMR System
FDA premarket approval P970029/S040 · decided 2022-09-01
Approval details
- PMA number
- P970029
- Supplement
- S040
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CardioGenesis TMR System
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2022-08-04
- Decision date
- 2022-09-01
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for the addition of chassis grounding resistance and chassis leakage current tests to the service manual for use after repair, maintenance, and installation activities.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PhotoFix Decellularized Bovine Pericardium (K183635) | Cryolife, Inc. | 2019-02-14 |
| PhotoFix Decellularized Bovine Pericardium (K172085) | Cryolife, Inc. | 2017-12-04 |
| PhotoFix Decellularized Bovine Pericardium (K162506) | Cryolife, Inc. | 2017-03-09 |
| PERCLOT TOPICAL (K132105) | Cryolife, Inc. | 2014-04-03 |
| PROPATCH SOFT TISSUE REPAIR MATRIX (K110581) | Cryolife, Inc. | 2012-01-10 |
| PROPATCH SOFT TISSUE REPAIR MATRIX (K101587) | Cryolife, Inc. | 2010-09-16 |
| CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866) | Cryolife, Inc. | 2010-07-23 |
| CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (K092021) | Cryolife, Inc. | 2010-05-25 |