|
Device | Durata and Optisure High Voltage Leads |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S133 |
Date Received | 05/22/2020 |
Decision Date | 06/18/2020 |
Product Code |
LWS |
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 Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol. |