• 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 | HDE | 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 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.
 
DevicePERFLUORON
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 south freeway r3-48
fort worth, TX 76134
PMA NumberP950018
Supplement NumberS008
Date Received12/26/2001
Decision Date07/29/2002
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING BLISTER PACKAGING TO THE VIAL PRODUCT THAT IS THEN SUBJECTED TO A STEAM STERILIZATION PROCESS IN ORDER TO PROVIDE A FINISHED PRODUCT VIAL WITH A STERILE EXTERIOR. ALSO, APPROVAL OF A 10 ML VIAL FOR THE 7 ML FILL PRODUCT TO ALLOW STERILIZATION HEADSPACE.
-
-