Genesis Neurostimulation System
FDA premarket approval P010032/S181 · decided 2021-11-03
Approval details
- PMA number
- P010032
- Supplement
- S181
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Genesis Neurostimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-10-01
- Decision date
- 2021-11-03
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Consolidate the Electrical testing at the cleaning step and QC inspection step of the manufacturing process and for the consolidated step to be performed after the Weld tip/Leak test step using automated CAMI lead test system in the Abbott Medical Puerto Rico, LLC manufacturing site.
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