VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS
FDA premarket approval P960040/S023 · decided 2001-06-27
Approval details
- PMA number
- P960040
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2001-06-06
- Decision date
- 2001-06-27
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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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