FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Microspheres Radionuclide
PMA: P200029
·
Supplement: S008
·
Decision Feb 7, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- TheraSphereTM Y-90 Glass Microspheres System
- PMA Number
- P200029
- Supplement Number
- S008
- Device Class
- FDA Class 3
- Product Code
- NAW
- Generic Name
- Microspheres radionuclide
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 7, 2024
- Date Received
- January 19, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval to implement ISO 80369 compliant luers in the TheraSphere Administration Sets manufactured by CEA Medical Manufacturing (CEA)
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 |
|---|---|---|---|
| NAW | Microspheres Radionuclide | FDA class 3 | Unknown |