VIGOR DR/SR PACEMAKER SYSTEM
FDA premarket approval P940031/S069 · decided 2010-09-14
Approval details
- PMA number
- P940031
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR DR/SR PACEMAKER SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-08-23
- Decision date
- 2010-09-14
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
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