|
Device | VENTAK PRIZM DR/VR HE AICD |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S014 |
Date Received | 06/05/2000 |
Decision Date | 07/13/2000 |
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 SOFTWARE THAT CONTROLS PROGRAM/RECORDER/MONITORS MODELS 2901 AND 2910. |