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PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS

FDA premarket approval P030017/S156 · decided 2013-05-08

Approval details

PMA number
P030017
Supplement
S156
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2013-02-20
Decision date
2013-05-08
Days to decision
77 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
APPROVAL FOR A COLORANT CHANGE TO THE HUB PORTION OF THE INTRODUCER, ASURGICAL ACCESSORY FOR THE PRECISION SPINAL CORD STIMULATION SYSTEM THAT IS USED TO FACILITATE PLACEMENT OF A LEAD INTO THE EPIDURAL SPACE.

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