Infinity Family of Implantable Pulse Generators
FDA premarket approval P140009/S027 · decided 2018-03-11
Approval details
- PMA number
- P140009
- Supplement
- S027
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Infinity Family of Implantable Pulse Generators
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-07-28
- Decision date
- 2018-03-11
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for a manufacturing site located at St. Jude Medical-Puerto Rico, Lot A Interior-No. 2 St. Km 67.5, Santana Industrial Park, Arecibo, Puerto Rico for manufacturing and sterilization of the Proclaim and Infinity neurostimulation systems.
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