FDA.reportPublic FDA data

PMA P170003S012

Device
LUTONIX 035 Drug Coated Balloon PTA Catheter
Applicant
Lutonix
PMA number
P170003
Supplement
S012
Product code
PRC
Decision date
2019-10-02
Classification
Drug-coated Peripheral Transluminal Angioplasty Catheter
Generic name
Drug-coated peripheral transluminal angioplasty catheter
Approval order statement
Approval for updates to your device labeling to communicate safety information regarding paclitaxel-coated devices for treatment of femoropopliteal arterial disease.

Current openFDA PMA Record#

Device
LUTONIX 035 Drug Coated Balloon PTA Catheter
Applicant
Lutonix
PMA number
P170003
Supplement
S012
Product code
PRC
Generic name
Drug-coated peripheral transluminal angioplasty catheter
Decision date
2019-10-02
Decision code
APPR
Date received
2019-09-18
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates to your device labeling to communicate safety information regarding paclitaxel-coated devices for treatment of femoropopliteal arterial disease.