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.
For removing the needleless luer component from the therasphere administration sets
Device | TheraSphere |
Generic Name | Microspheres Radionuclide |
Applicant | Boston Scientific Corporation |
Date Received | 2021-07-22 |
Decision Date | 2021-08-19 |
PMA | P200029 |
Supplement | S002 |
Product Code | NAW |
Advisory Committee | Radiology |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
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 |