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.
| Device | TheraSphere |
| Generic Name | Microspheres Radionuclide |
| Applicant | Boston Scientific Corporation300 Boston Scientific Waymarlborough, MA 01752 PMA NumberP200029 Supplement NumberS004 Date Received11/02/2022 Decision Date12/02/2022 Product Code NAW Advisory Committee Radiology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-11-02 |
| Decision Date | 2022-12-02 |
| PMA | P200029 |
| Supplement | S004 |
| 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 PMA NumberP200029 Supplement NumberS004 Date Received11/02/2022 Decision Date12/02/2022 Product Code NAW Advisory Committee Radiology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of The Revised 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. |
| 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 |