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Device | CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 South Freeway Fort Worth, TX 76134 |
PMA Number | P990023 |
Supplement Number | S008 |
Date Received | 09/15/2009 |
Decision Date | 10/15/2009 |
Product Code |
LZP |
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 ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM. |