This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval to add a 20 gram and a 125 gram aluminum lecture bottlesize for the referenced devices
| Device | ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS |
| Generic Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Applicant | Airgas USA, LLC |
| Date Received | 1996-08-23 |
| Decision Date | 1996-09-24 |
| PMA | P900067 |
| Supplement | S002 |
| Product Code | LPO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Airgas USA, LLC 6141 Easton Road plumsteadville, PA 18949 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900067 | Original Filing | |
| S007 | 2011-12-22 | 30-day Notice |
| S006 | 2009-08-13 | Special (immediate Track) |
| S005 | 2008-11-09 | 30-day Notice |
| S004 | ||
| S003 | 2001-12-26 | Special (immediate Track) |
| S002 | 1996-08-23 | Normal 180 Day Track |
| S001 |