Trade Name | CONTAK AND RENEWAL FAMILIES |
Classification Name | pulse-generator, dual chamber, implantable |
Generic Name | cardiac resynchronization therapy defibrillator (crt-d) system |
Applicant | GUIDANT CORP. |
PMA Number | P960040 |
Supplement Number | S126 |
Date Received | 05/05/2006 |
Decision Date | 08/08/2006 |
Product Code |
|
Advisory Committee |
Cardiovascular
|
Supplement Type |
normal 180 day track |
Supplement Reason | change design/components/specifications - component |
Expedited Review Granted? |
No
|
Approval Order Statement
Latitude patient management system model 6481 inductive communicator & software v1.
2.
0 and regulated application server (ras) v2.
0.
3.
|