| 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 | SALINE-FILLED BREAST IMPLANTS |
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| Classification Name | prosthesis, breast, inflatable, internal, saline |
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| Generic Name | silicone inflatable breast prosthesis |
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| Regulation Number | 878.3530 |
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| Applicant | ALLERGAN |
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| PMA Number | P990074 |
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| Supplement Number | S001 |
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| Date Received | 08/28/2000 |
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| Decision Date | 12/06/2000 |
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| Product Code | |
| Advisory Committee |
General & Plastic Surgery |
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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 manufacturing site located at mcghan medico, s. A. , barreal de heredia, cost rica. |
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