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Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon

by The Spectranetics Corp.

PMA P160049

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P160049↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP160049 Date26 Jul 2017ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
PMA Number
FDA Product Code
ONU
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon is a drug-eluting peripheral transluminal angioplasty catheter designed for percutaneous transluminal angioplasty (PTA). It is intended for treating de novo or restenotic lesions in native superficial femoral or popliteal arteries, with reference vessel diameters ranging from 4 to 6 mm and lesion lengths up to 180 mm.

This device is supplied as a single-use, over-the-wire (OTW) balloon catheter and requires appropriate vessel preparation prior to use. It is classified as a Class III medical device under FDA regulations and has received Premarket Approval (PMA) under PMA number P160049. The device is intended for use in controlled clinical settings and must adhere to sterile packaging and handling protocols as specified by the manufacturer.