Ranger™ Paclitaxel-Coated PTA Balloon Catheter

FDA Premarket Approval P190019

Pre-market Approval Supplement Details

Approval for the ranger™ paclitaxel-coated pta balloon catheter. This device is indicated for percutaneous transluminal angioplasty (pta) of de novo or restenotic lesions up to 180 mm in length located in native superficial femoral and proximal popliteal arteries (sfa/ppa) with reference vessel diameters of 4 - 8 mm.

DeviceRanger™ Paclitaxel-Coated PTA Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Date Received2019-07-22
Decision Date2020-10-30
PMAP190019
SupplementS
Product CodeONU 
Advisory CommitteeCardiovascular
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
S002 2020-11-09 30-day Notice
S001

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