|
Device | SJM DURATA, RIATA ST OPTIM & RIATA ST FAMILIES OF DEFIBRILLATION LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S055 |
Date Received | 01/14/2009 |
Decision Date | 06/18/2009 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF AN AUTOMATED HEAT SHRINKING PROCESS. |