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Precision Spectra and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems

FDA premarket approval P030017/S327 · decided 2019-09-13

Approval details

PMA number
P030017
Supplement
S327
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Precision Spectra and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2019-06-17
Decision date
2019-09-13
Days to decision
88 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Approval for the addition of the 50 cm Infinion CX Lead (SC-2317-50) and the 50 cm Artisan MRI lead (SC-8416-50) to the head-only MR conditional labeling for the Precision Spectra and Spectra WaveWriter spinal cord stimulator (SCS) systems.

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