| Trade Name | BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID |
| Generic Name | VISCOELASTIC OPTHALMO-SURGICAL AID AGENT |
| Applicant | FERRING PHARMACEUTICALS, INC. |
| PMA Number | P960011 |
| Recent Supplement Number | S021 |
| Contact | 4 GATEHALL DRIVE, THIRD FLOOR PARSIPPANY, NJ, 07054 |
| Date Received | Mar 09, 2012 |
| Decision Date | Mar 30, 2012 |
| Product Code | LZP |
| Advisory Committee | OP |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | ALTERNATE USE OF A NEW SYRINGEABILITY MACHINE FOR QC TESTING. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S020 | Jan 27, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | NEW VISCOMETER, FOR THE IN-PROCESS AND QUALITY CONTROL RELEASE TESTING. |
| S019 | Apr 01, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ALTERNATE RHEOMETER FOR TESTING IN-PROCESS CONTROL AND FINISHED PRODUCT SAMPLES. |
| S018 | Mar 08, 2011 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR THE INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE. IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE. |
| S017 | Jun 15, 2010 | PROCESS CHANGE: STERILIZATION/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR A CHANGE IN MANUFACTURE USING NEW EQUIPMENT. |
| S015 | Jan 07, 2010 | /30-DAY NOTICE | CHANGE IN THE LAYOUT OF THE MANUFACTURING FACILITY AND RELOCATION OF THE DISSOLUTION VESSEL AND MICROFILTRATION SYSTEM. |
| S016 | Jan 07, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED DEVICE. |
| S014 | Dec 16, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN PRESSURE SET POINTS DURING SODIUM HYALURONATE FERMENTATION. |
| S013 | Feb 29, 2008 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | CHANGE IN THE STERILIZATION CYCLE. |
| S011 | Sep 13, 2007 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD. |
| S012 | Dec 19, 2006 | LABELING CHANGE - TRADE NAME/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL TO CHANGE THE TRADE NAME FROM BIOLON TO BD1% OVD. |
| S010 | Sep 15, 2005 | LABELING CHANGE - TRADE NAME/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES. |
| S009 | Jan 27, 2005 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | APPROVAL FOR A CHANGE IN MANUFACTURING SITE TO THE BIO-TECHNOLOGY GENERAL, LTD. FACILITY IN BE'ER TUVIA, ISRAEL, AND FOR A CHANGE IN THE SPECIFICATIONS FOR THE ACTIVE PHARMACEUTICAL PRODUCT IN BIOLON. |
| S007 | Nov 01, 2002 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | APPROVAL FOR A NEW STERILIZATION FACILITY LOCATED AT MEDIPLAST ISRAEL, LTD., YAVNEM, ISRAEL |
| S008 | Apr 01, 2002 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | APPROVAL FOR AN ALTERNATE STERILIZATION AND FINAL CARTONING FACILITY LOCATED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA. |
| S004 | Mar 23, 2001 | LOCATION CHANGE: DISTRIBUTOR/NORMAL 180 DAY TRACK | APPROVAL FOR CIBA VISION TO MARKET BIOLON(TM) 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY IN THE UNITED STATES UNDER THE TRADE NAME "UNIVISC". |
| S006 | Mar 08, 2001 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL TO CHANGE THE CLEANING IN PLACE AND STERILIZATION IN PLACE PROCESSES AND INTRODUCE AN EQUILIBRATION STEP IN THE MANUFACTURING OF BIOLON(TM). |
| S005 | May 19, 2000 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued. |
| S003 | Sep 02, 1999 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade. |
| S002 | Jul 01, 1999 | PROCESS CHANGE: MANUFACTURING/NORMAL 180 DAY TRACK | Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the BioLon(TM) syringes. |
| S001 | Sep 09, 1998 | LOCATION CHANGE: DISTRIBUTOR/NORMAL 180 DAY TRACK | Approval for Akorn, Inc. to distribute BioLon(TM) in the United States. |
| Jul 16, 1998 | Original Approval | The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery. |