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 | TELIGEN 4-SITE MODELS |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
BOSTON SCIENTIFIC |
4100 hamline avenue north |
st. paul, MN 55112 |
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PMA Number | P960040 |
Supplement Number | S198 |
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
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Review Memo |
Review Memo
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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
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