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 | RELAY |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910020 |
Supplement Number | S026 |
Date Received | 12/03/2004 |
Decision Date | 12/22/2004 |
Withdrawal Date
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07/20/2012 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS. |
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