FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P100045
·
Supplement: S012
·
Decision Nov 16, 2016
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
- S012
- 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
- November 16, 2016
- Date Received
- October 17, 2016
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to the Hospital System Guide for the CardioMEMS HF System to clarify the instructions for powering down the hospital electronics unit (CM3000), and more detailed instructions for the Merlin.net setup and access.
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 |