- Device
- CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S017
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2010-04-15
- Decision code
- APPR
- Date received
- 2010-03-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.¿