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PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

FDA premarket approval P030017/S168 · decided 2013-08-06

Approval details

PMA number
P030017
Supplement
S168
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2013-05-22
Decision date
2013-08-06
Days to decision
76 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
APPROVAL FOR A CHANGE OF THE OUTER BOX USED AS SECONDARY PACKAGINGFOR THE PRECISION SPECTRA IMPLANTED PULSE GENERATOR, AND THE SPECTRA OPERATING ROOM CABLE/EXTENSION KITS.

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