• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS260
Date Received09/13/2012
Decision Date09/05/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for multiple design changes, packaging changes, labeling changes, manufacturing process changes, and a manufacturing facility transfer to technical services for electronics, inc. , tse taiwan manufacturing facility, with packaging activities to occur at the tse facility in jackson, minnesota for the 2090 ec/ecl ecg cable and lead wires and 148743 ecg plug.
Approval Order Approval Order
-
-