Ranger Paclitaxel-Coated Balloon Catheter

FDA Premarket Approval P190019 S009

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

Implementation of new manufacturing equipment

DeviceRanger Paclitaxel-Coated Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Date Received2021-03-24
Decision Date2021-04-01
PMAP190019
SupplementS009
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Boston Scientific Corporation three Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P190019Original Filing
S009 2021-03-24 30-day Notice
S008
S007 2021-02-24 30-day Notice
S006 2021-01-27 30-day Notice
S005 2020-12-08 30-day Notice
S004 2020-11-25 Normal 180 Day Track No User Fee
S003
S002 2020-11-09 30-day Notice
S001

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.