TheraSphere

FDA Premarket Approval P200029 S002

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

For removing the needleless luer component from the therasphere administration sets

DeviceTheraSphere
Generic NameMicrospheres Radionuclide
ApplicantBoston Scientific Corporation
Date Received2021-07-22
Decision Date2021-08-19
PMAP200029
SupplementS002
Product CodeNAW 
Advisory CommitteeRadiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P200029Original Filing
S002 2021-07-22 Real-time Process
S001 2021-04-15 Normal 180 Day Track No User Fee

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