| 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 | NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS |
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| Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
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| Regulation Number | 878.3540 |
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| Applicant | Allergan
2525 DUPONT DR.
IRVINE, CA 92612 |
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| PMA Number | P040046 |
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| Supplement Number | S009 |
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| Date Received | 09/15/2014 |
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| Decision Date | 03/13/2015 |
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| Product Code |
FTR |
| Advisory Committee |
General & Plastic Surgery |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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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 FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT LABEL, I.E., THE PRODUCT LABELS NO LONGER SERVE AS A TAMPER EVIDENT LABEL; AND7) CHANGES TO THE HEAT SEALING PROCESS (NEW PARAMETERS: TEMPERATURE = 236-256 DEGREE F, DWELL TIME = 4.9-6.9 S, PRESSURE = 60-80 PSI). |
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