SCS EPG Header
FDA premarket approval P010032/S147 · decided 2019-03-26
Approval details
- PMA number
- P010032
- Supplement
- S147
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCS EPG Header
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-12-26
- Decision date
- 2019-03-26
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for design changes including increasing the thickness of the polyimide substrate and decreasing the thickness of the polyimide coverfilm on the Flex Printed Circuit Board (PCB) on the Spinal Cord Stimulation External Pulse Generator (SCS EPG) header, model 3032.
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