Approval for theraspheretm. This device is indicated for use as selective internal radiation therapy (sirt) for local tumor control of solitary tumors (1-8 cm in diameter), in patients with unresectable hepatocellular carcinoma (hcc), child-pugh score a cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.
| Device | TheraSphere |
| Generic Name | Microspheres Radionuclide |
| Applicant | Boston Scientific Corporation |
| Date Received | 2020-06-24 |
| Decision Date | 2021-03-17 |
| PMA | P200029 |
| Supplement | S |
| Product Code | NAW |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00191506025564 | P200029 | 000 |
| 00191506025373 | P200029 | 000 |
| 00191506025366 | P200029 | 000 |
| 00191506025359 | P200029 | 000 |
| 00191506025342 | P200029 | 000 |
| 00191506025335 | P200029 | 000 |
| 00191506025328 | P200029 | 000 |
| 00191506025311 | P200029 | 000 |
| 00191506025304 | P200029 | 000 |
| 00191506025298 | P200029 | 000 |
| 00191506025281 | P200029 | 000 |
| 00191506025274 | P200029 | 000 |
| 00191506025267 | P200029 | 000 |
| 00191506025250 | P200029 | 000 |
| 00191506025243 | P200029 | 000 |
| 00191506025236 | P200029 | 000 |
| 00191506025380 | P200029 | 000 |
| 00191506025397 | P200029 | 000 |
| 00191506025557 | P200029 | 000 |
| 00191506025533 | P200029 | 000 |
| 00191506025526 | P200029 | 000 |
| 00191506025519 | P200029 | 000 |
| 00191506025502 | P200029 | 000 |
| 00191506025496 | P200029 | 000 |
| 00191506025489 | P200029 | 000 |
| 00191506025472 | P200029 | 000 |
| 00191506025465 | P200029 | 000 |
| 00191506025458 | P200029 | 000 |
| 00191506025441 | P200029 | 000 |
| 00191506025434 | P200029 | 000 |
| 00191506025427 | P200029 | 000 |
| 00191506025410 | P200029 | 000 |
| 00191506025403 | P200029 | 000 |
| 00191506025229 | P200029 | 000 |