|
Device | ISPAN SULFUR HEXAFLUORIDE SF6 GAS |
Generic Name | Gases used within eye to place pressure on detached retina |
Regulation Number | 886.4270 |
Applicant | Airgas Therapeutics LLC 6141 Easton Road Plumsteadville, PA 18949 |
PMA Number | P900067 |
Supplement Number | S006 |
Date Received | 08/13/2009 |
Decision Date | 01/13/2010 |
Product Code |
LPO |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |