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 | S011 |
Date Received | 07/14/2009 |
Decision Date | 08/14/2013 |
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 MODIFIED STABILITY PROTOCOL, A CHANGE IN THE PACKAGING TO AN ALTERNATE ALUMINUM SEAL WITH A FLIP-OFF CAP, AND THE ADDITION OF A PRE-PROCESSING MODIFICATION TO SILICONIZE THE STOPPERS USED IN THE FILLING, STOPPING, AND SEALING OF PERFLUORON.. |
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