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PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

FDA premarket approval P030017/S152 · decided 2014-08-26

Approval details

PMA number
P030017
Supplement
S152
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2013-01-28
Decision date
2014-08-26
Days to decision
575 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
APPROVAL FOR THE ADDITION OF THE COVEREDGE 4X8 SURGICAL LEAD (ALSO REFERRED TO AS THE 32 CONTACT PADDLE LEAD) AND PADDLE BLANKS TO BE USED WITH THE PRECISION SPECTRA SPINAL CORD STIMULATION SYSTEM.

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