Eterna SCS IPG
FDA premarket approval P010032/S205 · decided 2023-10-26
Approval details
- PMA number
- P010032
- Supplement
- S205
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Eterna SCS IPG
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-09-22
- Decision date
- 2023-10-26
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- approval for alternate resistor component changes in the printed circuit board assembly (PCBA) of the Eterna Spinal Cord Stimulation (SCS) System's implantable pulse generator (IPG)
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