CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM
FDA premarket approval P970029/S017 · decided 2010-04-15
Approval details
- PMA number
- P970029
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2010-03-19
- Decision date
- 2010-04-15
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR MODIFICATION OF AN EXISTING WARNING STATEMENT TO STATE: ¿EACH HANDPIECE DELIVERY SYTEM IS SUPPLIED STERILE FOR SINGLE USE ONLY. DO NOT REUSE OR RESTERILIZE. ANY ATTEMPT TO CLEAN AND RESTERILIZE CAN DAMAGE THE FIBEROPTIC.¿
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|---|---|---|
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| 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 |