Ranger Paclitaxel-Coated PTA Balloon Catheter

FDA Premarket Approval P190019 S004

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 protocols for the post-approval studies (pas) referenced above. The pas protocols have been submitted to comply with the conditions of approval outlined in our approval order for p190019.

DeviceRanger Paclitaxel-Coated PTA Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Date Received2020-11-25
Decision Date2020-12-16
PMAP190019
SupplementS004
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
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
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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