|
Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S084 |
Date Received | 10/03/2005 |
Decision Date | 11/02/2005 |
Product Code |
NVZ |
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 ALTERNATE MANUFACTURING PROCESS CHANGE TO ALLOW COMPONENT CURING IN AN AUTOCLAVE SYSTEM, WITH SUBSEQUENT REDUCTION IN PROCESS TIME. |