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 | AMO(R) VITRAX(R) VISCOELASTIC SOLUTION |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place Santa Ana, CA 92705 |
PMA Number | P880031 |
Supplement Number | S011 |
Date Received | 12/26/1995 |
Decision Date | 04/09/1997 |
Withdrawal Date
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03/03/2011 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT ALLERGAN BOTOX, LTD., WESTPORT, COUNTY MAYO, IRELAND; AN ALTERNATE CONTRACT STERILIZATION FACILITY, ISOTRON IRELAND, LTD., TULLAMORE, COUNTY OFFALY, IRELAND; AND AN 18 MONTH SHELF LIFE. |
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