|
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 | S005 |
Date Received | 11/09/2008 |
Decision Date | 12/09/2008 |
Product Code |
LPO |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE OF SULFUR HEXAFLUORIDE GAS SUPPLIER. |