|
Device | VENTAK PRIZM IMPLANTABLE CARIOVERTER DEFIBRILLATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S021 |
Date Received | 02/26/2001 |
Decision Date | 04/05/2001 |
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 VENTAK(R) PRIZM(TM) MODEL 2844 SOFTWARE APPLICATION, VERSION 3.3. |