FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Temporary Non-Roller Type Left Heart Support Blood Pump
PMA: P140003
·
Supplement: S038
·
Decision Aug 28, 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 2.5, Impella CP, Impella 5.0 and Impella LD
- PMA Number
- P140003
- Supplement Number
- S038
- 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
- August 28, 2018
- Date Received
- July 31, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
changes to the manufacturing of Impella 2.5, CP, 5.0, and LD.
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 |