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 | DURATA LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S079 |
Date Received | 11/07/2011 |
Decision Date | 09/13/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE HELIX-SHAFT SUBASSEMBLY OF MARKET APPROVED TENDRIL MODELS 1882, 1888, 1988, 2088 AND DURATA MODELS 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, AND 7131 LEADS FOR IMPROVED MANUFACTURABILITY AND COST. |
Approval Order | Approval Order |
|
|