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. |
|
Device | MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR 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 | S004 |
Date Received | 10/19/2009 |
Decision Date | 03/31/2011 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00853593
|
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 THE ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD. THE MODEL 4396 LEAD IS A 4 FRENCH, TRANSVENOUS, STEROID ELUTING, DUAL ELECTRODE, POLYURETHANE INSULATED, SINGLE COIL, STRAIGHT TIP, TINE FIXATION LEAD INTENDED FOR USE IN LEFT HEART CORONARY VEINS. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |
|
|