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 | APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) |
Generic Name | Programmer, pacemaker |
Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. Sylmar, CA 91342 |
PMA Number | P900070 |
Supplement Number | S028 |
Date Received | 12/24/2002 |
Decision Date | 01/22/2003 |
Withdrawal Date
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06/20/2007 |
Product Codes |
DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODEL 3307 (VERSION 4.1A) PROGRAMMER SOFTWARE FOR SJM MODELS 3500/3510 PROGRAMMER. |
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