|
Device | ATTTAIN ABILITY |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P080006 |
Supplement Number | S062 |
Date Received | 11/26/2013 |
Decision Date | 12/18/2013 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00271544
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement UPDATE TO THE VALIDATED RANGES OF THE ELUTION AND DETERMINATION OF RELATED SUBSTANCES METHODS USED IN RELEASE TESTING ATTAIN ABILITY LEADS. |
Post-Approval Study | Show Report Schedule and Study Progress |