Infinity DBS IPGs
FDA premarket approval P140009/S056 · decided 2020-05-06
Approval details
- PMA number
- P140009
- Supplement
- S056
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Infinity DBS IPGs
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-04-06
- Decision date
- 2020-05-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Supplier manufacturing site location change for the Flex Assembly component used in the manufacture of Proclaim and Infinity Implantable Pulse Generator devices.
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