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 for changes to the labeling to include clarification of the gas pressure restriction listed on the gas cylinder label and enhanced instruction for filling a syringe with ispan hexafluoride sf6 gas.
| Device | ISPAN SULFUR HEXAFLUORIDE SF6 GAS |
| Generic Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Applicant | Airgas USA, LLC |
| Date Received | 2009-08-13 |
| Decision Date | 2010-01-13 |
| PMA | P900067 |
| Supplement | S006 |
| Product Code | LPO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |