The information provided by the firm is adequate to support the proposed change to the firm’s manufacturing procedure and method of manufacturing. I recommend that an email be sent to the applicant indicating they may distribute the device incorporating the change.
| Device | ISPAN Perfluoropropane C3F8 Gas |
| Generic Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Applicant | Airgas Therapeutics LLC |
| Date Received | 2022-01-06 |
| Decision Date | 2022-02-02 |
| PMA | P900066 |
| Supplement | S015 |
| Product Code | LPO |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Airgas Therapeutics 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