FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Permanent Defibrillator Electrodes
PMA: P240036
·
Supplement: S006
·
Decision Apr 24, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Permanent Defibrillator Electrodes
- Trade Name
- OmniaSecure MRI SureScan Lead Model 3930M
- PMA Number
- P240036
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- NVY
- Generic Name
- Permanent defibrillator electrodes
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 24, 2026
- Date Received
- March 25, 2026
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240036/S004.
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 |