SOLARGEN 2100S LASER
FDA premarket approval P970029/S012 · decided 2008-09-11
Approval details
- PMA number
- P970029
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SOLARGEN 2100S LASER
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2008-08-15
- Decision date
- 2008-09-11
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SOLARGEN 2100S LASER USER MANUAL.
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