PMA P160049S018

Device: Stellarex 035 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S018
Product code: ONU
Decision date: 2022-06-22
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 catheter assembly of the Stellarex 035 Drug Coated Balloon.

Current openFDA PMA Record#

Device: Stellarex 035 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter
Applicant: The Spectranetics Corp.
PMA number: P160049
Supplement: S018
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2022-06-22
Decision code: APPR
Date received: 2022-04-01
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 catheter assembly of the Stellarex 035 Drug Coated Balloon.