|
Device | ECLIPSE TMR HOLMIUN LASER SYSTEM |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 |
PMA Number | P970029 |
Supplement Number | S003 |
Date Received | 12/06/1999 |
Decision Date | 03/22/2000 |
Product Code |
MNO |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of a new test fiber and four new labels. |
Post-Approval Study | Show Report Schedule and Study Progress |