FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Permanent Defibrillator Electrodes
PMA: P920015
·
Supplement: S304
·
Decision Mar 6, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P920015 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Permanent Defibrillator Electrodes
- Trade Name
- HV Splitter/ Adaptor kit
- PMA Number
- P920015
- Supplement Number
- S304
- Device Class
- FDA Class 3
- Product Code
- NVY
- Generic Name
- Permanent defibrillator electrodes
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 6, 2026
- Date Received
- February 6, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to replace the Novec 72DA solvent with the PWR-4 3910 solvent during the component cleaning process
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 |
|---|---|---|---|
| NVY | Permanent Defibrillator Electrodes | FDA class 3 | Unknown |