FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Leadless Cardiac Resynchronization Therapy (Crt)
PMA: P240028
·
Supplement: S004
·
Decision Dec 15, 2025
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
- S004
- 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
- December 15, 2025
- Date Received
- November 17, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to update manufacturing lot release testing requirements for M1000 and M2000 catheters.
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 |