|
Device | LATTITUDE PATIENT MANAGEMENT SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S123 |
Date Received | 07/27/2012 |
Decision Date | 09/25/2012 |
Product Codes |
LWS NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM APPLICATION SERVER SOFTWARE V7.03.0 1 ON LATITUDE SYSTEM SERVER (MODEL 6488). |