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PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM

FDA premarket approval P030017/S235 · decided 2016-04-28

Approval details

PMA number
P030017
Supplement
S235
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2015-09-10
Decision date
2016-04-28
Days to decision
231 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
addition of the PrecisionTM MontageTM MRI and PrecisionTM MontageTM System Components

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