• 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.
 
DeviceMEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS246
Date Received02/08/2016
Decision Date04/21/2016
Product Code LKK 
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes.
-
-