Charger, Model 16000
FDA premarket approval P010032/S206 · decided 2023-12-19
Approval details
- PMA number
- P010032
- Supplement
- S206
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Charger, Model 16000
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-09-25
- Decision date
- 2023-12-19
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for an alternate cell battery part number from an existing supplier for Abbotts Charger Model 16000.
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