| 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 Silicon-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 | P020056 |
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| Supplement Number | S046 |
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| Date Received | 12/18/2017 |
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| Decision Date | 06/27/2018 |
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| Product Code |
FTR |
| Advisory Committee |
General & Plastic Surgery |
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| Supplement Type | 135 Review Track For 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Approval to implement an additional incoming specification, i.e., verify the color of the gel material by using the Ultra Scan VIS Sensor System to confirm that the gel color does not change between shipment and receipt. There are no changes to existing incoming specification, manufacturing process, and final device specifications. The addition of this assessment is specific to the 900 Parkway Global Park, La Aurora, Heredia, Costa Rica manufacturing site. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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