PMA P160049S010

Device: Stellarex 0.035” OTW Drug-coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
Product code: ONU
Decision date: 2021-10-28
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Approval for a manufacturing site located at Philips Image Guided Therapy Devices, 5905 Nathan Lane North, Plymouth, MN for a site change of the analytical laboratory for stability testing of Stellarex 0.035” 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: S010
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2021-10-28
Decision code: APPR
Date received: 2020-12-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Philips Image Guided Therapy Devices, 5905 Nathan Lane North, Plymouth, MN for a site change of the analytical laboratory for stability testing of Stellarex 0.035” Drug Coated Angioplasty Balloon.