FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Microspheres Radionuclide
PMA: P990065
·
Supplement: S009
·
Decision Mar 24, 2017
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Microspheres Radionuclide
- Trade Name
- SIR-Spheres microspheres
- PMA Number
- P990065
- Supplement Number
- S009
- 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
- March 24, 2017
- Date Received
- August 8, 2016
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at Sirtex Germany Manufacturing GMBH, Industriepark Hoechst, Building G808 65926 Frankfurt am Main Germany.
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 |