| 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 | AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM |
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| Classification Name | implantable pacemaker pulse-generator |
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| Generic Name | pulse generator |
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| Regulation Number | 870.3610 |
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| Applicant | SIEMENS-PACESETTER, INC. |
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| PMA Number | P880086 |
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| Supplement Number | S034 |
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| Date Received | 10/02/1995 |
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| Decision Date | 11/13/1995 |
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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 | process change: sterilization |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the incorporation of a "nitrogen blanket" to the sterilization process used at the sylmar, ca, facility of pacesetter, inc. |
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