FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Microspheres Radionuclide
PMA: P200029
·
Supplement: S010
·
Decision Sep 24, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- TheraSphere
- PMA Number
- P200029
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- NAW
- Generic Name
- Microspheres radionuclide
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 24, 2024
- Date Received
- May 28, 2024
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
for labeling update with the results obtained from the post-approval study
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 |