TheraSphere™

FDA Premarket Approval P200029 S001

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.

Pre-market Approval Supplement Details

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.

DeviceTheraSphere™
Generic NameMicrospheres Radionuclide
ApplicantBoston Scientific Corporation
Date Received2021-04-15
Decision Date2021-05-14
PMAP200029
SupplementS001
Product CodeNAW 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P200029Original Filing
S001 2021-04-15 Normal 180 Day Track No User Fee

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