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Precision Spectra & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S

FDA premarket approval P030017/S257 · decided 2016-09-29

Approval details

PMA number
P030017
Supplement
S257
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Spectra & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2016-08-31
Decision date
2016-09-29
Days to decision
29 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Modify the software used to test the printed circuit board assembly in the Remote Control of your Spinal Cord Stimulation systems.

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510(k) clearances by this applicant

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EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
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