|
Device | WORLD HEART NOVACOR N100PC AND N100PCQ :VAS |
Generic Name | Ventricular (assist) bypass |
Applicant | WORLD HEART, INC. 7799 PARDEE LN. OAKLAND, CA 94621 |
PMA Number | P980012 |
Supplement Number | S006 |
Date Received | 03/10/2004 |
Decision Date | 07/21/2004 |
Withdrawal Date
|
07/15/2011 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL. |