HEART LASER CO2 TMR SYSTEM
FDA premarket approval P950015/S003 · decided 1999-11-10
Approval details
- PMA number
- P950015
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HEART LASER CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 1999-05-14
- Decision date
- 1999-11-10
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- Approval for a new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the TMR Disposable Kit (an accessory for The Heart Laser(TM) System). In addition, approval is requested to extend the shelf life for the TMR Disposable Kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.
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