PMA P130024S008

Device: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Applicant: Lutonix
PMA number: P130024
Supplement: S008
Product code: ONU
Decision date: 2015-11-24
Classification: Drug-eluting Peripheral Transluminal Angioplasty Catheter
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILS REGARDING THE USE OF BARE METAL STENTS WITH THE DEVICE FOR BAILOUT STENTING.

Current openFDA PMA Record#

Device: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Applicant: Lutonix
PMA number: P130024
Supplement: S008
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2015-11-24
Decision code: APPR
Date received: 2015-11-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILS REGARDING THE USE OF BARE METAL STENTS WITH THE DEVICE FOR BAILOUT STENTING.