PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems

FDA premarket approval P030017/S275 · decided 2017-08-11

Approval details

PMA number

P030017

Supplement

S275

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

Boston Scientific Corp

Date received

2016-12-27

Decision date

2017-08-11

Days to decision

227 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Valencia, CA

Statement

Approval for expanding indications to include Complex Regional Pain Syndrome (CRPS) Types I and II and the following associated conditions and etiologies: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, and multiple back surgeries.

510(k) clearances by this applicant