Prometra Programmable Infusion Pump System

FDA Premarket Approval P080012 S064

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

Minor software changes (correction of firmware errors) to bring the prometra ii programmable pumps (20ml and 40ml) back into specification to match the performance as reflected in the original software requirements.

DevicePrometra Programmable Infusion Pump System
Generic NamePump, Infusion, Implanted, Programmable
ApplicantFLOWONIX MEDICAL, INC.
Date Received2019-12-27
Decision Date2020-01-15
PMAP080012
SupplementS064
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address FLOWONIX MEDICAL, INC. 500 International Drive suite 200 mt.olive, NJ 07828

Supplemental Filings

Supplement NumberDateSupplement Type
P080012Original Filing
S064 2019-12-27 Special (immediate Track)
S063
S062 2019-08-16 Real-time Process
S061
S060 2019-07-25 Real-time Process
S059 2019-07-16 30-day Notice
S058 2019-05-09 Real-time Process
S057
S056
S055 2019-02-04 30-day Notice
S054
S053 2018-11-19 30-day Notice
S052
S051 2018-05-21 Real-time Process
S050 2018-02-06 Normal 180 Day Track
S049
S048
S047 2017-09-19 Real-time Process
S046 2017-06-16 Real-time Process
S045 2017-06-08 Normal 180 Day Track No User Fee
S044 2017-05-31 Special (immediate Track)
S043 2017-05-10 30-day Notice
S042 2017-05-03 Real-time Process
S041 2017-05-01 Special (immediate Track)
S040 2017-04-12 Normal 180 Day Track
S039 2017-02-28 Special (immediate Track)
S038
S037 2016-09-20 Real-time Process
S036 2016-09-16 135 Review Track For 30-day Notice
S035 2016-08-05 30-day Notice
S034
S033 2016-02-26 Real-time Process
S032 2015-10-26 30-day Notice
S031 2015-10-20 Normal 180 Day Track No User Fee
S030 2015-10-13 Real-time Process
S029 2015-06-04 Real-time Process
S028 2015-05-18 Normal 180 Day Track No User Fee
S027
S026
S025 2015-03-09 30-day Notice
S024 2014-11-17 Real-time Process
S023 2014-09-15 Normal 180 Day Track
S022 2014-06-30 Normal 180 Day Track
S021 2014-04-28 Normal 180 Day Track
S020 2014-04-22 30-day Notice
S019 2013-08-09 Normal 180 Day Track
S018 2013-06-04 30-day Notice
S017 2013-05-03 Special (immediate Track)
S016 2013-04-05 Real-time Process
S015
S014 2013-03-12 30-day Notice
S013 2013-03-04 Real-time Process
S012 2013-02-01 Normal 180 Day Track No User Fee
S011 2013-01-24 Real-time Process
S010 2013-01-08 30-day Notice
S009 2012-10-10 30-day Notice
S008
S007 2012-08-17 30-day Notice
S006 2012-08-16 30-day Notice
S005
S004 2012-04-20 Real-time Process
S003 2012-03-06 Normal 180 Day Track No User Fee
S002 2012-03-06 Normal 180 Day Track No User Fee
S001 2012-03-06 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00810335020082 P080012 000
00810335020143 P080012 000
00810335020136 P080012 000
00810335020129 P080012 000
00810335020082 P080012 000
00810335020099 P080012 000
00810335020150 P080012 000
00810335020129 P080012 000
00810335020136 P080012 000
00810335020143 P080012 000
00810335020150 P080012 000
00810335020099 P080012 000
00810335020105 P080012 019
00810335020105 P080012 019
00810335020167 P080012 021
00810335020167 P080012 021
00810335020228 P080012 022
00810335020228 P080012 022
00810335020174 P080012 023
00810335020181 P080012 023
00810335020174 P080012 023
00810335020181 P080012 023

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