Spinal Cord Stimulation (SCS) System
FDA premarket approval P010032/S169 · decided 2021-02-24
Approval details
- PMA number
- P010032
- Supplement
- S169
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-10-28
- Decision date
- 2021-02-24
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval to change the grade in raw materials used in the formulation of the Green Solvent, used for in-process cleaning of leads and pins.
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