|
Device | THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS) |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S029 |
Date Received | 07/05/2013 |
Decision Date | 08/05/2013 |
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 ADDITION OF THORATEC CORPORATION AS A SECONDARY SOURCE FOR THE ASSEMBLY OF THE 14V BATTERY CLIPS FOR THE THORATEC® HEARTMATE® II VENTRICULAR ASSIST SYSTEM (LVAS). |