|
Device | ATTAIN ABILITY MODEL 4X96 LEAD |
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 | S063 |
Date Received | 11/27/2013 |
Decision Date | 05/15/2014 |
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 |
Review Memo | Review 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 Order | Approval Order |