|
Device | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S037 |
Date Received | 06/23/2014 |
Decision Date | 07/17/2014 |
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 MANUFACTURING PROCESS CHANGES TO THE PRINTED CIRCUIT BOARD (PCB) OF THE DEVICE CONTROLLER. |