FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Microspheres Radionuclide
PMA: P200029
·
Supplement: S009
·
Decision Apr 5, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- TheraSphere
- PMA Number
- P200029
- Supplement Number
- S009
- 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
- April 5, 2024
- Date Received
- March 14, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval to enhance the criteria for visual sampling and inspection of the TheraSphere Administration Sets manufactured by B. Braun Medical Inc. during primary inspection at B. Braun and consequently reducing visual sampling and inspection during secondary inspection at BWXT Medical Ltd
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 |