PMA P160049S015

Device: Stellarex 0.035OTW Drug-coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S015
Product code: ONU
Decision date: 2022-03-25
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Approval for The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon. The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 180 mm in length in superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

Current openFDA PMA Record#

Device: Stellarex 0.035OTW Drug-coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S015
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2022-03-25
Decision code: APPR
Date received: 2021-09-29
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon. The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 180 mm in length in superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.