Implantable System for Remodulin

FDA Premarket Approval P140032 S053

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 change requested to modify the procedure for the assessment of device bioburden at medtronic's final device manufacturing facilities-medtronic puerto rico operations company, located in juncos, puerto rico. The change also requested other related administrative changes which update the procedure. The change impacts bundled pma p970004/s310, p840001/s461, p860004/s356, p140032/s053, p960009/s374, p080025/s205, h020007/s269, and h050003/s238.

DeviceImplantable System for Remodulin
Generic NamePump, Infusion, Implanted, Programmable
ApplicantMedtronic, Inc.
Date Received2020-04-09
Decision Date2020-05-08
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic, Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432-5604

Supplemental Filings

Supplement NumberDateSupplement Type
P140032Original Filing
S055 2020-04-24 30-day Notice
S054 2020-04-16 30-day Notice
S053 2020-04-09 30-day Notice
S052 2020-03-23 30-day Notice
S051 2020-03-11 30-day Notice
S050 2020-03-09 30-day Notice
S048 2019-12-23 Special (immediate Track)
S046 2019-12-10 30-day Notice
S045 2019-12-10 30-day Notice
S044 2019-11-25 30-day Notice
S043 2019-11-15 30-day Notice
S042 2019-09-27 30-day Notice
S041 2019-08-30 30-day Notice
S040 2019-08-09 30-day Notice
S039 2019-08-08 30-day Notice
S038 2019-07-26 30-day Notice
S037 2019-07-16 30-day Notice
S035 2019-06-06 30-day Notice
S034 2019-05-06 30-day Notice
S033 2019-04-26 30-day Notice
S031 2019-04-01 30-day Notice
S030 2019-03-07 30-day Notice
S029 2019-02-28 30-day Notice
S028 2019-02-27 30-day Notice
S027 2019-02-22 30-day Notice
S026 2019-01-09 30-day Notice
S025 2018-12-26 Real-time Process
S023 2018-12-11 30-day Notice
S022 2018-10-30 Special (immediate Track)
S021 2018-10-19 30-day Notice
S020 2018-08-20 Normal 180 Day Track
S019 2018-08-15 30-day Notice
S017 2018-07-25 Special (immediate Track)
S016 2018-07-17 30-day Notice
S015 2018-07-02 30-day Notice
S014 2018-06-18 30-day Notice
S013 2018-06-01 Real-time Process
S012 2018-05-24 30-day Notice
S011 2018-05-16 30-day Notice
S010 2018-05-16 30-day Notice
S009 2018-05-07 30-day Notice
S008 2018-05-07 30-day Notice
S007 2018-05-02 30-day Notice
S006 2018-04-20 Special (immediate Track)
S005 2018-04-18 Normal 180 Day Track No User Fee
S004 2018-04-16 30-day Notice
S003 2018-03-12 30-day Notice
S002 2018-02-01 Normal 180 Day Track
S001 2018-01-22 Normal 180 Day Track No User Fee

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