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Precision Spectra and Spectra WaveWriter Spinal Cord Stimulator

FDA premarket approval P030017/S292 · decided 2017-06-19

Approval details

PMA number
P030017
Supplement
S292
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Spectra and Spectra WaveWriter Spinal Cord Stimulator
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2017-05-22
Decision date
2017-06-19
Days to decision
28 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Adding a maximum of five (5) minute transfer time at ambient conditions from a vacuum bake oven to a laser welder for the Precision Spectra and the Spectra Wave Writer Implantable Pulse Generators (IPGs).

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