Infinity IPG
FDA premarket approval P140009/S035 · decided 2018-01-10
Approval details
- PMA number
- P140009
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Infinity IPG
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-12-18
- Decision date
- 2018-01-10
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Alternate supplier manufacturing location for the drilling process for the Bluetooth (BLE) antenna (this also included new equipment models). The BLE antenna is a component of the spinal cord stimulation (SCS) and deep brain stimulation (DBS) implantable pulse generator (IPGs) headers.
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