FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Microspheres Radionuclide
PMA: P200029
·
Supplement: S007
·
Decision Dec 18, 2023
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- TheraSphere
- PMA Number
- P200029
- Supplement Number
- S007
- 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
- December 18, 2023
- Date Received
- November 27, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the manufacturing change to allow the ball mill to be used as an optional alternative to the mortar and pestle in the final frit crushing step.
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 |