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 MODEL 4X96 LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis,, MN 55432
PMA NumberP080006
Supplement NumberS063
Date Received11/27/2013
Decision Date05/15/2014
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) ELUTION METHOD AND SPECIFICATIONS, TRANSFER OF THE MCRD MANUFACTURING LOCATION, USE OF A SURROGATE TIP COMPONENT FOR MCRD TESTING, AND UPDATES TO THE MCRD SHELF LIFE PROTOCOL FOR ATTAIN ABILITY LEAD MODELS 4196, 4296 AND 4396.
Approval OrderApproval Order
-
-