Device |
microspheres radionuclide |
Definition |
Approved PMA: P990065 |
Review Panel |
Radiology |
Product Code | NAW |
Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|