FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Electrical, Implantable, For Incontinence
PMA: P970004
·
Supplement: S444
·
Decision Feb 12, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stimulator, Electrical, Implantable, For Incontinence
- Trade Name
- SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531
- PMA Number
- P970004
- Supplement Number
- S444
- Device Class
- FDA Class 3
- Product Code
- EZW
- Generic Name
- Stimulator, electrical, implantable, for incontinence
- Regulation Number
- 876.5270
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 12, 2026
- Date Received
- January 13, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZW | Stimulator, Electrical, Implantable, For Incontinence | FDA class 3 | Gastroenterology, Urology |