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.
|Generic Name||Microspheres Radionuclide|
|Applicant||Boston Scientific Corporation|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol|
|Applicant Address||Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752|
|Supplement Number||Date||Supplement Type|
|S001||2021-04-15||Normal 180 Day Track No User Fee|