Implantable System for Remodulin

FDA Premarket Approval P140032 S048

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

Removal of the delrin tool from the manufacturing procedure for the implantable system for remodulin.

DeviceImplantable System for Remodulin
Generic NamePump, Infusion, Implanted, Programmable
ApplicantMedtronic, Inc.
Date Received2019-12-23
Decision Date2020-01-22
PMAP140032
SupplementS048
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement TypeSpecial (immediate Track)
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
S048 2019-12-23 Special (immediate Track)
S047
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
S036
S035 2019-06-06 30-day Notice
S034 2019-05-06 30-day Notice
S033 2019-04-26 30-day Notice
S032
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
S024
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
S018
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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