IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

FDA Premarket Approval P140010 S066

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

DeviceIN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantMEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS066 Date Received06/28/2022 Decision Date07/08/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-28
Decision Date2022-07-08
PMAP140010
SupplementS066
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMEDTRONIC Inc.
3576 Unocal Pl
santa Rosa, CA 95403 PMA NumberP140010 Supplement NumberS066 Date Received06/28/2022 Decision Date07/08/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
additional Controls Be Added To The Luer Inspection And Gluing Processes.

Supplemental Filings

Supplement NumberDateSupplement Type
P140010Original Filing
S066 2022-06-28 30-day Notice
S065
S064 2022-06-14 30-day Notice
S063 2021-11-12 30-day Notice
S062
S061
S060 2021-04-23 Special (immediate Track)
S059 2021-03-30 30-day Notice
S058 2021-03-04 30-day Notice
S057
S056 2021-02-25 30-day Notice
S055 2021-01-19 30-day Notice
S054 2020-11-23 30-day Notice
S053
S052 2020-10-02 30-day Notice
S051 2020-07-10 Normal 180 Day Track No User Fee
S050
S049 2020-01-23 30-day Notice
S048 2019-11-20 30-day Notice
S047 2019-08-30 Special (immediate Track)
S046 2019-05-31 30-day Notice
S045 2019-05-02 30-day Notice
S044 2019-04-11 30-day Notice
S043 2018-10-25 Real-time Process
S042 2018-10-10 Normal 180 Day Track No User Fee
S041 2018-09-24 30-day Notice
S040
S039 2018-03-19 Normal 180 Day Track
S038
S037 2017-12-08 Panel Track
S036 2017-07-20 30-day Notice
S035 2017-06-28 30-day Notice
S034 2017-06-13 30-day Notice
S033 2017-06-01 135 Review Track For 30-day Notice
S032 2017-05-25 Real-time Process
S031 2017-04-18 30-day Notice
S030 2017-03-08 30-day Notice
S029 2017-02-17 30-day Notice
S028 2017-01-12 30-day Notice
S027 2016-11-18 30-day Notice
S026 2016-10-07 Normal 180 Day Track No User Fee
S025 2016-09-12 30-day Notice
S024 2016-08-02 135 Review Track For 30-day Notice
S023 2016-07-29 Normal 180 Day Track No User Fee
S022 2016-07-19 30-day Notice
S021 2016-07-13 30-day Notice
S020 2016-06-20 30-day Notice
S019 2016-05-26 30-day Notice
S018 2016-05-25 135 Review Track For 30-day Notice
S017 2016-04-06 Special (immediate Track)
S016 2016-03-22 30-day Notice
S015 2016-03-11 Panel Track
S014 2016-03-02 30-day Notice
S013 2015-11-24 Normal 180 Day Track
S012 2015-11-05 135 Review Track For 30-day Notice
S011 2015-10-28 30-day Notice
S010 2015-09-18 30-day Notice
S009 2015-07-21 Normal 180 Day Track No User Fee
S008
S007 2015-07-10 Real-time Process
S006 2015-04-21 Real-time Process
S005 2015-03-20 135 Review Track For 30-day Notice
S004 2015-03-18 30-day Notice
S003 2015-01-27 Normal 180 Day Track No User Fee
S002 2015-01-26 Normal 180 Day Track No User Fee
S001 2014-12-30 30-day Notice

NIH GUDID Devices

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