| 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 | KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 350 |
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| Classification Name | implantable pacemaker pulse-generator |
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| Generic Name | implantable pulse generator programming software |
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| Regulation Number | 870.3610 |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P980035 |
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| Supplement Number | S025 |
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| Date Received | 12/03/2002 |
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| Decision Date | 02/21/2003 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | location change: manufacturer |
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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 move of the eoc manufacturing operations in kerkrade, the netherlands to eoc, medtronic b. V. , heerlen, the netherlands. |
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