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Precision Spinal Cord Stimulator (SCS Systems)

FDA premarket approval P030017/S361 · decided 2023-05-12

Approval details

PMA number
P030017
Supplement
S361
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Spinal Cord Stimulator (SCS Systems)
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2023-05-04
Decision date
2023-05-12
Days to decision
8 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Remove the Verify Multi-lumen Tube Length step currently performed at the BSC Dorado manufacturing site during the assembly of the 15cm Precision M8 Adapter, Precision M8 Trial Adapter, and Vercise M8 Adapter of the Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) systems.

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