Ranger Paclitaxel-Coated PTA Balloon Catheter

FDA Premarket Approval P190019 S005

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

Addition of equipment to the manufacturing line

DeviceRanger Paclitaxel-Coated PTA Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Date Received2020-12-08
Decision Date2021-01-07
PMAP190019
SupplementS005
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
S017 2022-11-03 30-day Notice
S016 2022-10-17 30-day Notice
S015 2022-10-06 30-day Notice
S014 2022-09-15 30-day Notice
S013 2022-01-28 30-day Notice
S012 2022-01-25 30-day Notice
S011
S010 2021-12-20 30-day Notice
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

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