PMA P130024S013

Device: LUTONIX 035 DRUG COATED BALLOON PTA CATETER
Applicant: Lutonix
PMA number: P130024
Supplement: S013
Product code: ONU
Decision date: 2016-11-09
Classification: Drug-eluting Peripheral Transluminal Angioplasty Catheter
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Approval for a manufacturing site located at Lutonix Inc., 9409 Science Center Drive, New Hope, Minnesota to manufacture 7mm balloons.

Current openFDA PMA Record#

Device: LUTONIX 035 DRUG COATED BALLOON PTA CATETER
Applicant: Lutonix
PMA number: P130024
Supplement: S013
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2016-11-09
Decision code: APPR
Date received: 2016-06-15
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 Lutonix Inc., 9409 Science Center Drive, New Hope, Minnesota to manufacture 7mm balloons.