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Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spexctra WaveWriter Spinal Co

FDA premarket approval P030017/S325 · decided 2019-04-05

Approval details

PMA number
P030017
Supplement
S325
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spexctra WaveWriter Spinal Co
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2019-03-12
Decision date
2019-04-05
Days to decision
24 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Environmental monitoring control change and sampling plan update at the Boston Scientific Corporation, St. Paul, Minnesota facility.

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