Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
FDA premarket approval P010032/S159 · decided 2020-03-04
Approval details
- PMA number
- P010032
- Supplement
- S159
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-02-03
- Decision date
- 2020-03-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Implementation of an alternative sampling plan for bacterial endotoxin testing performed at the Arecibo, Puerto Rico facility.
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510(k) clearances by this applicant
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|---|---|---|
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