LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010

Drug-coated Peripheral Transluminal Angioplasty Catheter

FDA Premarket Approval P170003 S014

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The revised protocol and informed consent for the new enrollment pas registry

DeviceLUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010
Classification NameDrug-coated Peripheral Transluminal Angioplasty Catheter
Generic NameDrug-coated Peripheral Transluminal Angioplasty Catheter
ApplicantLUTONIX
Date Received2019-10-03
Decision Date2019-11-26
PMAP170003
SupplementS014
Product CodePRC
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product Yes
Applicant Address LUTONIX 9409 Science Center Drive new Hope, MN 55428

Supplemental Filings

Supplement NumberDateSupplement Type
P170003Original Filing
S014 2019-10-03 Normal 180 Day Track No User Fee
S013
S012 2019-09-18 Special (immediate Track)
S011
S010
S009
S008 2019-04-25 Normal 180 Day Track No User Fee
S007
S006 2019-02-26 Real-time Process
S005
S004 2018-10-04 Real-time Process
S003 2018-06-20 30-day Notice
S002 2018-05-18 Special (immediate Track)
S001 2017-09-25 Normal 180 Day Track No User Fee

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