Proclaim SCS IPG
FDA premarket approval P010032/S145 · decided 2018-12-06
Approval details
- PMA number
- P010032
- Supplement
- S145
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Proclaim SCS IPG
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-11-08
- Decision date
- 2018-12-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Supplier requested change to add alternate second tier suppliers of elemental lithium and electrolyte, which are materials used to build the lithium primary cell batteries used in Orion family implantable pulse generator (IPG) devices.
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