ECLIPSE TMR HOLMIUM LASER SYSTEM
FDA premarket approval P970029/S005 · decided 2000-12-08
Approval details
- PMA number
- P970029
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ECLIPSE TMR HOLMIUM LASER SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2000-11-09
- Decision date
- 2000-12-08
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR TWO SPECIFIC ADDITIONAL QUALITY CONTROL INSPECTION STEPS DURING THE MANUFACTURING OF THE SOLOGRIP HANDPIECE AND THE ADDITION OF SPECIFIC LANGUAGE IN THREE PLACES TO THE INSTRUCTIONS FOR USE FOR THE SOLOGRIP HANDPIECE.
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