HEART LASER CO2 TMR SYSTEM
FDA premarket approval P950015/S012 · decided 2014-07-23
Approval details
- PMA number
- P950015
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEART LASER CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 2013-10-07
- Decision date
- 2014-07-23
- Days to decision
- 289 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHOX, IN BUFFALO, NEW YORK.
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