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 | MODEL 3510 PROGRAMMER/ 3303 SOFTWARE |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S060 |
Date Received | 03/24/1999 |
Decision Date | 04/21/1999 |
Product Code |
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 the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers. |
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