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. |
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Device | ECLIPSE TMR HOLMIUM LASER SYSTEM |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 |
PMA Number | P970029 |
Supplement Number | S001 |
Date Received | 03/26/1999 |
Decision Date | 09/17/1999 |
Product Code |
MNO |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a proposed post-approval study protocol. In addition, all advertising and promotional materials must include the warning aobut the use of TMR in a patient with unstable angina, the need for patients to sign a consent form and the requirements that apply to the training of practitioners who may use the device. |
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