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. |
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Device | MEDTRONIC ATTAIN STARFIX |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P060039 |
Supplement Number | S003 |
Date Received | 07/21/2008 |
Decision Date | 01/16/2009 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |
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