Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | CADENCE FAMILY OF ICDS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S270 |
Date Received | 07/19/2011 |
Decision Date | 03/09/2012 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00916929
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES. |
Approval Order | Approval Order |
|
|