Approval for the following changes: use of an alternate fluorotec s2-f451w stopper; changes in the aseptic filling and packaging processes to use the cbl autobloc automated filling line; an alternate fill volume (2 ml) for perfluoron in a unit package; a new master batch record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.
| Device | PERFLURON |
| Classification Name | Fluid, Intraocular |
| Generic Name | Fluid, Intraocular |
| Applicant | ALCON LABORATORIES |
| Date Received | 1999-02-11 |
| Decision Date | 1999-03-05 |
| PMA | P950018 |
| Supplement | S002 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 South Freeway R3-48 fort Worth, TX 76134 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950018 | | Original Filing |
| S021 |
2022-07-18 |
30-day Notice |
| S020 |
2021-10-26 |
30-day Notice |
| S019 |
2020-06-29 |
30-day Notice |
| S018 |
2015-03-26 |
30-day Notice |
| S017 | | |
| S016 |
2012-11-08 |
Normal 180 Day Track |
| S015 |
2012-01-30 |
Real-time Process |
| S014 |
2010-11-22 |
30-day Notice |
| S013 |
2010-03-05 |
30-day Notice |
| S012 | | |
| S011 |
2009-07-14 |
Normal 180 Day Track |
| S010 |
2008-04-15 |
Normal 180 Day Track No User Fee |
| S009 |
2003-02-14 |
Real-time Process |
| S008 |
2001-12-26 |
Real-time Process |
| S007 |
2001-07-13 |
30-day Notice |
| S006 |
2001-04-24 |
30-day Notice |
| S005 |
2001-02-26 |
30-day Notice |
| S004 |
2000-02-17 |
Normal 180 Day Track |
| S003 |
1999-03-26 |
Normal 180 Day Track |
| S002 |
1999-02-11 |
Real-time Process |
| S001 |
1996-10-17 |
Normal 180 Day Track |
NIH GUDID Devices