← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

EZW — Stimulator, Electrical, Implantable, For Incontinence

PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

DEVICE CLASS
Class III
REGULATION
21 CFR 876.5270
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P180046Boston Scientific Corporation · pma2026-06-17
P970004Medtronic Neuromodulation · pma2026-06-16
P240031Neuspera Medical, Inc. · pma2026-04-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA 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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