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 | AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S106 |
Date Received | 07/27/2005 |
Decision Date | 08/25/2005 |
Product Codes |
DTB DXY KRG |
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 CHANGE OF THE MANUAL EPOXY DISPENSING METHOD TO A SEMI-AUTOMATED ROBOT CONTROLLED EPOXY DISPENSING SYSTEM. |
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