FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
PMA: P030054
·
Supplement: S439
·
Decision Nov 20, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P030054 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
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Trade Name
- Quartet and QuickFlex µ Left Heart Leads
- PMA Number
- P030054
- Supplement Number
- S439
- Device Class
- FDA Class 3
- Product Code
- NIK
- Generic Name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 20, 2025
- Date Received
- September 10, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for model line extensions for the Zenex MRI & Zenus MRI families of pacemakers and updated labeling for cardiac leads and additional pacemaker models
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 |
|---|---|---|---|
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | FDA class 3 | Unknown |