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.
 
DeviceSYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS056
Date Received04/07/2003
Decision Date09/12/2003
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM WHICH INCLUDES MODEL 8637 SYNCHROMED II PROGRAMMABLE PUMP, SYNCHROMED II APPLICATION SOFTWAARE ON THE MODEL 8870 APPLICATION CARD, MODEL 8551 REFILL KIT, MODEL 8540 CATHETER ACCESS PORT KIT, AND MODEL 8590-1 POUCH KIT.
Post-Approval StudyShow Report Schedule and Study Progress
-
-