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Precision Montage MRI Spinal Cord Stimulator (SCS) Systems

FDA premarket approval P030017/S304 · decided 2017-10-31

Approval details

PMA number
P030017
Supplement
S304
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Montage MRI Spinal Cord Stimulator (SCS) Systems
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2017-10-03
Decision date
2017-10-31
Days to decision
28 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
use of an alternate bonding method during the manufacture of the telemetry coil, an electronic component on the Printed Circuit Board Assembly (PCBA) of the Precision Montage MRI Spinal Cord Stimulator (SCS) Systems

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510(k) clearances by this applicant

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