FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Temporary Non-Roller Type Left Heart Support Blood Pump
PMA: P140003
·
Supplement: S031
·
Decision Apr 16, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Temporary Non-Roller Type Left Heart Support Blood Pump
- Trade Name
- Impella CP System
- PMA Number
- P140003
- Supplement Number
- S031
- Device Class
- FDA Class 3
- Product Code
- OZD
- Generic Name
- Temporary non-roller type left heart support blood pump
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 16, 2018
- Date Received
- April 5, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Implement a 2X ETO sterilization process for the Impella CP Optical 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 |
|---|---|---|---|
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | FDA class 3 | Unknown |