Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter

FDA Premarket Approval P190019 S015

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

DeviceRanger-Over-The-Wire Paclitaxel Coated Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS015 Date Received10/06/2022 Decision Date11/10/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-06
Decision Date2022-11-10
PMAP190019
SupplementS015
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressBoston Scientific Corporation
three Scimed Place
maple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS015 Date Received10/06/2022 Decision Date11/10/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
a Change To The Cut To Length Manufacturing Process

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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