FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Microspheres Radionuclide
PMA: P990065
·
Supplement: S017
·
Decision Apr 11, 2025
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- SIR-SPHERES
- PMA Number
- P990065
- Supplement Number
- S017
- 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 11, 2025
- Date Received
- March 14, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a change in manufacturing to update the number of vendor vials from one Y-90 vendor vial to two Y-90 vendor vials that can be used to manufacture SIR-Spheres bulk batch volumes of 42 mL to 52 mL
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 |