FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P100045
·
Supplement: S008
·
Decision May 2, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- System, Hemodynamic, Implantable
- Trade Name
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
- PMA Number
- P100045
- Supplement Number
- S008
- 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
- May 2, 2016
- Date Received
- March 15, 2016
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for an alternate contract sterilizer site located at St Jude Medical-Sylmar, 15900 Valley View Court, Sylmar, California, 93342, to perform as an alternate ethylene oxide sterilization vendor for the CardioMEMS PA Sensor and Delivery 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 |