This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p200029.
| Device | TheraSphere™ |
| Generic Name | Microspheres Radionuclide |
| Applicant | Boston Scientific Corporation |
| Date Received | 2021-04-15 |
| Decision Date | 2021-05-14 |
| PMA | P200029 |
| Supplement | S001 |
| Product Code | NAW |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200029 | Original Filing | |
| S004 | 2022-11-02 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2021-07-22 | Real-time Process |
| S001 | 2021-04-15 | Normal 180 Day Track No User Fee |