VENTAK AV, VENTAK VR, VENTAK PRIZMALITY, VITALITY 2
FDA premarket approval P960040/S044 · decided 2004-05-14
Approval details
- PMA number
- P960040
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK AV, VENTAK VR, VENTAK PRIZMALITY, VITALITY 2
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-04-14
- Decision date
- 2004-05-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
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