Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
FDA premarket approval P010032/S161 · decided 2020-05-06
Approval details
- PMA number
- P010032
- Supplement
- S161
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-04-06
- Decision date
- 2020-05-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Implement an updated Helium Leak Test System Software used during assembly of Orion family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs).
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