FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Leadless Cardiac Resynchronization Therapy (Crt)
PMA: P240028
·
Supplement: S006
·
Decision Mar 27, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Leadless Cardiac Resynchronization Therapy (Crt)
- Trade Name
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- PMA Number
- P240028
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- SEG
- Generic Name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 27, 2026
- Date Received
- February 25, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
qualification of a new supplier for the IrOx coating process on the needle tip of the WiSE CRT System
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 |
|---|---|---|---|
| SEG | Leadless Cardiac Resynchronization Therapy (Crt) | FDA class 3 | Unknown |