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Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A

FDA premarket approval P030017/S357 · decided 2023-10-05

Approval details

PMA number
P030017
Supplement
S357
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2022-12-28
Decision date
2023-10-05
Days to decision
281 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Approval for expanding the indications to include diabetic peripheral neuropathy (DPN) of the lower extremities for paresthesia-based stimulation.

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