PMA P160049S012

Device: Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S012
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 Corporation, 5905 Nathan Lane North Plymouth, MN 55442, for manufacturing, including finished lot release testing and finished product testing, for the Stellarex 035 Drug Coated balloon.

Current openFDA PMA Record#

Device: Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S012
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2021-10-28
Decision code: APPR
Date received: 2021-05-07
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 Corporation, 5905 Nathan Lane North Plymouth, MN 55442, for manufacturing, including finished lot release testing and finished product testing, for the Stellarex 035 Drug Coated balloon.