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 (PURIFIED PERFLUORO-N-OCTANE LIQUID) |
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 | S001 |
Date Received | 10/17/1996 |
Decision Date | 12/11/1996 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION OF THE STABILITY PROTOCOL TO INCREASE THE ACCEPTANCE CRITERIA LIMIT FOR UV/VIS ABSORBANCE ON ACCELERATED AGIN (45 DEGREES C) SAMPLES FROM <0.2 TO <0.4 ABSORBANCE UNITS CM-1 AT 220NM |
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