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 | COGNIS 4-SITE MODELS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S212 |
Date Received | 05/11/2009 |
Decision Date | 11/10/2010 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR: 1) THE ELEVATED PRESSURE LABELING MODIFICATIONS FOR TELIGEN ICD MODELS E103, E111, E102 AND E110; AND 2) THE NEW 4-SITE HEADER FOR TELIGEN ICD MODELS E103 AND E111. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |
|
|