|
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 | S007 |
Date Received | 05/25/2001 |
Decision Date | 11/01/2001 |
Product Code |
MNO |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISIONS TO THE SOLOGRIP III INSTRUCTIONS FOR USE. |