PMA P950015
- Device
- HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S012
- Product code
- MNO
- Decision date
- 2014-07-23
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHOX, IN BUFFALO, NEW YORK.
Current openFDA PMA Record#
- Device
- HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S012
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2014-07-23
- Decision code
- APPR
- Date received
- 2013-10-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHOX, IN BUFFALO, NEW YORK.