CARDIOGENESIS TMR SYSTEM
FDA premarket approval P970029/S026 · decided 2014-05-07
Approval details
- PMA number
- P970029
- Supplement
- S026
- 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
- 2014-04-09
- Decision date
- 2014-05-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR INCLUDING THE POST APPROVAL STUDY LABELING CHANGES OF THE PEARL 8.0 DEVICE INTO THE INSTRUCTIONS FOR USE OF THE PEARL 5.0 AND THE SOLOGRIP III HANDPIECES AS WELL AS ADDING SOME CLARIFYING STATEMENTS TO ENSURE THE SAFE HANDLING OF THE HANDPIECES.
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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 |