| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | MEDTRONIC SYNCHROMED INFUSION SYSTEM |
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| Classification Name | pump, infusion, implanted, programmable |
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| Generic Name | implanted infusion pump |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P860004 |
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| Supplement Number | S037 |
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| Date Received | 02/28/1997 |
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| Decision Date | 06/28/1999 |
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| Product Code | |
| Docket Number | N |
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| Advisory Committee |
General Hospital |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - performance characteristics |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a labeling change to include the use of the synchromed infusion system in a magnetic resonance imaging (mri) environment. |
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