|
Device | THORATEC HEARTMATE II LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S004 |
Date Received | 12/24/2008 |
Decision Date | 12/04/2009 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW SEALED (GELWEAVE) OUTFLOW GRAFT WITH BEND RELIEF FOR USE WITH THE HEARTMATE II LVAS. |