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.
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.
|Device||Ranger Paclitaxel-Coated PTA Balloon Catheter|
|Generic Name||Drug-eluting Peripheral Transluminal Angioplasty Catheter|
|Applicant||Boston Scientific Corporation|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol - Ode/oir|
|Applicant Address||Boston Scientific Corporation three Scimed Place maple Grove, MN 55311-1566|
|Supplement Number||Date||Supplement Type|
|S004||2020-11-25||Normal 180 Day Track No User Fee|