Infinity Family of Implantable Pulse Generators
FDA premarket approval P140009/S032 · decided 2017-11-28
Approval details
- PMA number
- P140009
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2017-11-16
- Decision date
- 2017-11-28
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Supplier site move to a new supplier manufacturing location for ferrules used in the manufacture of battery lids within Implantable Pulse Generators (IPGs), in addition to a new Lid Assembly Machine (LAM) used to weld the ferrules to the battery lid.
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