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 | VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S015 |
Date Received | 06/08/2000 |
Decision Date | 08/04/2000 |
Product Codes |
KRG LWP |
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 PULSE GENERATOR MODELS 1860 AND 1861, PULSE GENERATOR SOFTWARE VERSION 1.3, AND PROGRAM/RECORDER/MONITOR SOFTWARE MODEL 2844, VERSION 3.1. |
|
|