← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
NE
ImplantLife-sustainingGMP-exemptThird-party review eligible
6
510(K)/PMA CLEARANCES
pma: 6
0
RECALL ENTRIES

Recent clearances

P010032ABBOTT MEDICAL · pma2026-07-17
P030017Boston Scientific Corp · pma2026-07-10
P840001Medtronic Neuromodulation · pma2026-07-01
P190002Saluda Medical Pty, Ltd. · pma2026-06-29
P210037Biotronik Nro, Inc. · pma2026-06-05
P130022Nevro Corporation · pma2025-08-15

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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