Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
DeviceISOMED CONSTANT FLOW INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP990034
Supplement NumberS001
Date Received10/30/2000
Decision Date11/20/2000
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE MODEL 8472 PUMP: 1) MODIFICATION OF THE MOUNTING OF THE BELLOWS INFUSATE RESERVOIR; 2) SLIGHT CHANGES IN THE CONFIGURATION OF FIVE COMPONENT PARTS IN ORDER TO MAINTAIN THE HEIGHTS OF THE PUMPS FOLLOWING THE CHANGE IN MOUNTING; AND 3) REQUIRED CHANGES IN FIVE WELDS TO FACILITATE THE PREVIOUSLY STATED MODIFICATIONS.
-
-