FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Microspheres Radionuclide
PMA: P990065
·
Supplement: S007
·
Decision Oct 9, 2014
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- SIR-SPHERE MICROSPHERES
- PMA Number
- P990065
- Supplement Number
- S007
- 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
- October 9, 2014
- Date Received
- September 9, 2014
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN OPTIONAL USE OF AN ALTERNATE NON-IONIC SOLUTION 5% DEXTROSE (D5W).
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 |