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 PULSE GENERATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S224 |
Date Received | 08/16/2010 |
Decision Date | 10/15/2010 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF SECOND SOURCE DIODE SUPPLIERS (ST MICRO AND MINCO TECHNOLOGY LABS) FOR THE HCVM AND SOM USED IN THE COGNIS AND TELIGEN PULSE GENERATORS. |
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