Approval for a change to the toxicity test protocol to increase the number of samples to be tested from each production lot of perfluoropropane from one sample per lot to three samples per lot.
| Device | PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY |
| 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 | 2000-08-18 |
| Decision Date | 2000-09-05 |
| PMA | P900066 |
| Supplement | S004 |
| Product Code | LPO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Airgas USA, LLC 6141 Easton Road plumsteadville, PA 18949 |
Supplemental Filings
| 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 | | |
NIH GUDID Devices