|
Device | PRIZM AND VITALITY FAMILIES |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S130 |
Date Received | 05/05/2006 |
Decision Date | 08/08/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3. |