Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | HEART LASER CO2 TMR SYSTEM |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | Laser Engineering Heart Inc. 475 Metroplex Drive, Suite 401 Nashville, TN 37211 |
PMA Number | P950015 |
Supplement Number | S012 |
Date Received | 10/07/2013 |
Decision Date | 07/23/2014 |
Withdrawal Date
|
11/06/2020 |
Product Code |
MNO |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHOX, IN BUFFALO, NEW YORK. |
|
|