• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceImplantable System for Remodulin (ISR)
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
Medtronic, Inc.
710 medtronic parkway ne
minneapolis, MN 55432-5604
PMA NumberP140032
Supplement NumberS011
Date Received05/16/2018
Decision Date06/15/2018
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes Medtronic Implantable System for Remodulin® (ISR) including changes to the manufacturing process and suppliers for the ISR pump, components and processes for the ISR catheter and changes to the number of nitrogen purges for the ISR Refill Kit.
-
-