• 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.
 
DeviceMYCARELINK PATIENT MONITOR, MYCARELINK READER FRU
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP890003
Supplement NumberS300
Date Received12/23/2013
Decision Date01/16/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE TEST EQUIPMENT/TEST METHOD USED IN THE QUALITY CONTROL INSPECTION PROCESS OF THE PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE MYCARELINK PATIENTMONITOR.
-
-