• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE
PMA NumberP900067
Supplement NumberS003
Date Received12/26/2001
Decision Date01/29/2002
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications to improve the patient's and doctor's knowledge regarding the hazards of using nitrous oxide for a subsequent surgical procedure when gas is still present in the eye.
-
-