VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM
FDA premarket approval P940031/S077 · decided 2014-05-07
Approval details
- PMA number
- P940031
- Supplement
- S077
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-04-22
- Decision date
- 2014-05-07
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
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