|
Device | DURATA FAMILY OF HIGH VOLTAGE LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S087 |
Date Received | 09/29/2014 |
Decision Date | 10/27/2014 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADD AN ALTERNATE AIR STRINGING PROCESS FOR THE CABLES USED IN THE LEADS. |