CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
FDA premarket approval P970029/S021 · decided 2012-09-13
Approval details
- PMA number
- P970029
- Supplement
- S021
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2012-08-16
- Decision date
- 2012-09-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THE DEVICE DESCRIPTION, WARNINGS, ADVERSE EFFECTS AND DEVICE OPERATING INSTRUCTIONS.
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