Eterna SCS IPG
FDA premarket approval P010032/S210 · decided 2024-05-02
Approval details
- PMA number
- P010032
- Supplement
- S210
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Eterna SCS IPG
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-02-05
- Decision date
- 2024-05-02
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- approval for the standardization of the presentation of dimensions of the Liberta RC DBS IPG (model 62400) and the Eterna SCS IPG (model 32400) within device labeling, basing them on nominal specification values via a computer-generated engineering model
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