|
Device | HEARTWARE VENTRICULAR ASSIST SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S066 |
Date Received | 10/19/2015 |
Decision Date | 12/10/2015 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF A CONNECTOR ASSEMBLY FIXTURE, CONNECTOR GLUING FIXTURE, ADDITIONAL INSPECTIONS DURING THE MANUFACTURING PROCESS AND TO MOVE THE CONTINUITY TEST TO FURTHER IN THE MANUFACTURING PROCESS. |