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Precision Spional Cord Stimulator (SCS) Systems

FDA premarket approval P030017/S375 · decided 2024-06-21

Approval details

PMA number
P030017
Supplement
S375
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Spional Cord Stimulator (SCS) Systems
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2024-05-24
Decision date
2024-06-21
Days to decision
28 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
the qualification of an alternate supplier, Integer, for the Proximal Contact and Distal Electrode components used in Boston Scientific Neuromodulation Spinal Cord Stimulation Leads and Deep Brain Stimulation Lead Extensions

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510(k) clearances by this applicant

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