PMA P160049S027

Device: Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S027
Product code: ONU
Decision date: 2025-11-24
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: for the implementation of an alternative paclitaxel active pharmaceutical ingredient utilized in the drug coating of the Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

Current openFDA PMA Record#

Device: Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S027
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-11-24
Decision code: APPR
Date received: 2025-08-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: for the implementation of an alternative paclitaxel active pharmaceutical ingredient utilized in the drug coating of the Stellarex 0.035" OTW Drug-coated Angioplasty Balloon