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 | EASYTRAK 3 IS-1 LEADS |
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 | S274 |
Date Received | 12/02/2011 |
Decision Date | 03/05/2012 |
Product Codes |
LWP OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING, |
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