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. |
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Device | VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S023 |
Date Received | 06/06/2001 |
Decision Date | 06/27/2001 |
Product Codes |
KRG LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT GUIDANT IRELAND, CLONMEL TIPPERARY, IRELAND AND ALTERNATE STERILIZATION FACILITIES LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND AND GUIDANT, ST. PAUL, MINNESOTA. |
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