FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P100045
·
Supplement: S045
·
Decision Aug 14, 2020
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- System, Hemodynamic, Implantable
- Trade Name
- CardioMEMS HS System
- PMA Number
- P100045
- Supplement Number
- S045
- Device Class
- FDA Class 3
- Product Code
- MOM
- Generic Name
- System, hemodynamic, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 14, 2020
- Date Received
- July 15, 2020
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Manufacturing process changes to the wafer bonding of the PA Pressure Sensor.
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 |