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.
 
DeviceATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432
PMA NumberP080006
Supplement NumberS087
Date Received12/28/2015
Decision Date01/25/2016
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
-
-