VENTAK AV/VR (VENTAK PRIZM)
FDA premarket approval P960040/S149 · decided 2007-09-28
Approval details
- PMA number
- P960040
- Supplement
- S149
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK AV/VR (VENTAK PRIZM)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-08-31
- Decision date
- 2007-09-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- AUTOMATION OF AN ADHESIVE APPLICATION PROCESS.
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