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 | THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S050 |
Date Received | 01/24/2012 |
Decision Date | 02/29/2012 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN. |
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