Premarket Approval (PMA)

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.

• 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 Rd.; 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
REPLACE THE ION CHROMATOGRAPH FOR QUALITY CONTROL PRODUCT TESTING.