This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | PERFLUOROPROPANE |
| Classification Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Generic Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Applicant | Airgas USA, LLC |
| Date Received | 1990-11-02 |
| Decision Date | 1993-02-25 |
| Notice Date | 1993-04-14 |
| PMA | P900066 |
| Supplement | S |
| Product Code | LPO |
| Docket Number | 93M-0097 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Airgas USA, LLC 6141 Easton Road plumsteadville, PA 18949 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900066 | Original Filing | |
| S015 | 2022-01-06 | 30-day Notice |
| S014 | ||
| S013 | 2021-08-31 | 30-day Notice |
| S012 | ||
| S011 | 2011-12-06 | 30-day Notice |
| S010 | 2010-07-19 | 30-day Notice |
| S009 | 2009-08-13 | Special (immediate Track) |
| S008 | 2008-07-21 | 135 Review Track For 30-day Notice |
| S007 | ||
| S006 | 2002-08-13 | 135 Review Track For 30-day Notice |
| S005 | 2001-12-26 | Special (immediate Track) |
| S004 | 2000-08-18 | Special (immediate Track) |
| S003 | 1999-09-21 | Normal 180 Day Track |
| S002 | 1996-08-23 | Normal 180 Day Track |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00380657971039 | P900066 | 000 |
| 00380657971022 | P900066 | 000 |
| 00380657971015 | P900066 | 000 |
| 00380657971053 | P900066 | 002 |
| 00380657971046 | P900066 | 002 |