Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


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 NamePERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantSCOTT MEDICAL PRODUCTS GROUP
PMA NumberP900066
Supplement NumberS003
Date Received09/21/1999
Decision Date03/16/2000
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
1)change in manufacturing site; 2)alternate synthesis route for perfluoropropane; and 3) changing release specification for the perfluoropropane gas.
-
-