TMR Holmium Laser System
FDA premarket approval P970029/S038 · decided 2021-01-21
Approval details
- PMA number
- P970029
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMR Holmium Laser System
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2018-11-02
- Decision date
- 2021-01-21
- Days to decision
- 811 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for a manufacturing site located at Parker Hannifin (CSS Merrillville), 1201 East 86th Place, Merrillville, Indiana 46410, for manufacturing of the SoloGrip III Handpiece which is part of the Cardiogenesis Laser System.
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 |
|---|---|---|
| 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 |