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 | VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE) |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | AIR PRODUCTS & CHEMICALS, INC. 7201 HAMILTON BLVD. ALLENTOWN, PA 18951-501 |
PMA Number | P910068 |
Supplement Number | S001 |
Date Received | 04/26/1999 |
Decision Date | 04/04/2001 |
Withdrawal Date
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06/27/2003 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 1) MANUFACTURING SITE CHANGE: THE NEW SITE FOR MANUFACTURING THE BULK MEDICAL GRADE PERFLUOROPERHYDROPHENANTHRENE (APF-215M) WILL BE AT FLUOROMED, L.P. (FMLP), ROUND ROCK, TEXAS 78664; 2) MANUFACTURING CHANGE: APF-215M WILL BE MANUFACTURED FROM PERFLUOROPERHYDROPHENANTHRENE RAW MATERIAL INSTEAD OF FROM PHENANTHRENE RAW MATERIAL; AND 3) APF-215M SPECIFICATION CHANGE REGARDING TESTING PARAMETER FOR LOWER BOILING COMPONENTS. |
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