FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Electrical, Implantable, For Incontinence
PMA: P970004
·
Supplement: S436
·
Decision Sep 15, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stimulator, Electrical, Implantable, For Incontinence
- Trade Name
- InterStim® Therapy System, Verify® Evaluation System
- PMA Number
- P970004
- Supplement Number
- S436
- 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
- September 15, 2025
- Date Received
- August 25, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to implement a new visual inspection between the feedthrough component and the tri-metal sputtered layer and to increase the frequency of the titanium chamber coating on the sputter equipment
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 |