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 | PERFLUORON |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R3-48 FORT WORTH, TX 76134 |
PMA Number | P950018 |
Supplement Number | S007 |
Date Received | 07/13/2001 |
Decision Date | 08/07/2001 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ELIMINATION OF FINISHED PRODUCT INTRAVITREAL TESTING FOR PERFLUORON AND REVISION OF THE "PURIFIED PERFLUORO-N-OCTANE ANALYTICAL TEST MONOGRAPH" REGARDING CALCULATION OF IMPURITIES. THE SPECIFICATION OF >=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED. |
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