|
Device | Durata and Optisure High Voltage Lead |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S112 |
Date Received | 10/23/2017 |
Decision Date | 05/17/2020 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for single shock coil passive fixation lead models (Durata 7172Q and Optisure LDP210Q) and changes to the crimp subassemblies. |