Brio IPG/Infinity IPG
FDA premarket approval P140009/S031 · decided 2017-11-21
Approval details
- PMA number
- P140009
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Brio IPG/Infinity IPG
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-11-13
- Decision date
- 2017-11-21
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Change to an approved supplier (Plastic Design Corporation (PDC)) manufacturing site location of the polysulfone port plug component of the St. Jude Medical Neurostimulation Systems.
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