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 | SILIKON 1000 |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | ALCON 6201 SOUTH FREEWAY MAIL DROP R7-14 FORT WORTH, TX 76134-2099 |
PMA Number | P950008 |
Supplement Number | S010 |
Date Received | 06/11/2013 |
Decision Date | 07/15/2013 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO THE SILIKON 1000 OIL DIRECTIONS FOR USE. |
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