FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P100045
·
Supplement: S023
·
Decision Apr 4, 2018
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
- S023
- 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
- April 4, 2018
- Date Received
- July 17, 2017
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change the tolerance for the hydrophilic coated length along the distal end of the catheter.
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 |