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.
 
DeviceMEDTRONIC ATTAIN STARFIX
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP060039
Supplement NumberS003
Date Received07/21/2008
Decision Date01/16/2009
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
Approval Order Statement  
APPROVAL FOR 1) USE OF NEW ANALYTICAL METHODS FOR ASSAY, CONTENT UNIFORMITY AND IDENTITY TESTING;2) TIGHTENING OF THE ASSAY SPECIFICATION RELATIVE TO THE LABEL CLAIM;3) MODIFICATION OF THE ELUTION SPECIFICATION WITH AN ADDITIONAL TIME POINT AND UPDATEDACCEPTANCE CRITERIA;4) MODIFICATION OF THE RESIDUAL SOLVENT SPECIFICATION;5) MODIFICATION OF THE APPEARANCE SPECIFICATION:6) USE OF A NEW LABORATORY FOR RELEASE AND STABILITY TESTING;7) USE OF NEW ASSAY, CONTENT UNIFORMITY, IDENTIFICATION, ELUTION AND RELATED SUBSTANCEANALYTICAL TEST METHODS DEVELOPED AT THE NEW LABORATORY;8) USE OF THE APPROVED APPEARANCE/ DESCRIPTION AND RESIDUAL SOLVENTS TEST METHODS AT THE NEW LABORATORY;9) USE OF THE NEW LABORATORY STERILITY TEST METHOD; AND10) UPDATE OF THE MODEL 4195 LEAD SHELF LIFE TO 12 MONTHS AND AGREEMENT THAT DRUG STABILITY DATA AT 18 MONTHS ARE ACCEPTABLE.
-
-