|
Device | SJM MODEL 3510 PROGRAMMER(FOR ATLAS II CRT-D)/MERLIN MODEL 3650 PROGRAMMER( FOR ATLAS II & PROMOTE CRT-D) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S200 |
Date Received | 01/21/2009 |
Decision Date | 05/07/2009 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |