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.
 
DeviceCONSULTA CRT-P, SYNCRA CRT-P
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP010015
Supplement NumberS157
Date Received03/07/2012
Decision Date06/04/2012
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR CONSULTA CRT-P MODEL C4TR01 AND SYNCRA CRT-P MODEL C2TR01.
Approval OrderApproval Order
-
-