FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Permanent Defibrillator Electrodes
PMA: P920015
·
Supplement: S305
·
Decision Apr 15, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Permanent Defibrillator Electrodes
- Trade Name
- ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu
- PMA Number
- P920015
- Supplement Number
- S305
- 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
- April 15, 2026
- Date Received
- March 31, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to reduce the bioburden monitoring frequency from bi-weekly to monthly
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 |