FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P100045
·
Supplement: S077
·
Decision Feb 6, 2025
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- System, Hemodynamic, Implantable
- Trade Name
- CardioMEMS HF System
- PMA Number
- P100045
- Supplement Number
- S077
- Device Class
- FDA Class 3
- Product Code
- MOM
- Generic Name
- System, hemodynamic, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 6, 2025
- Date Received
- July 5, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for version C2.0 of the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal and introduction of the CardioGuide HF Application for use with the CardioMEMS HF 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 |
|---|---|---|---|
| MOM | System, Hemodynamic, Implantable | FDA class 3 | Unknown |