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 | 3500/3510 PROGRAMMER |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S066 |
Date Received | 07/22/1999 |
Decision Date | 01/28/2000 |
Withdrawal Date
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06/20/2007 |
Product Code |
KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrrogation of implanted St. Jude pacemakers. |
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