VIGOR DR/SR/DISCOVER/MERIDIAN/PDP
FDA premarket approval P940031/S065 · decided 2009-11-16
Approval details
- PMA number
- P940031
- Supplement
- S065
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIGOR DR/SR/DISCOVER/MERIDIAN/PDP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-05-22
- Decision date
- 2009-11-16
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO ADD A NEW SOFTWARE SYSTEM.
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