Note: 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. |
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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 | S007 |
Date Received | 12/22/2011 |
Decision Date | 01/20/2012 |
Product Code |
LPO |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REPLACE THE ION CHROMATOGRAPH FOR QUALITY CONTROL PRODUCT TESTING. |
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