VENTAK PRIZM DR/VR HE AICD
FDA premarket approval P960040/S014 · decided 2000-07-13
Approval details
- PMA number
- P960040
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK PRIZM DR/VR HE AICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-06-05
- Decision date
- 2000-07-13
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE SOFTWARE THAT CONTROLS PROGRAM/RECORDER/MONITORS MODELS 2901 AND 2910.
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