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) | 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.
 
DeviceIPAFLUOROFOCON A AND B
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N Goodman St.
Rochester, NY 14692
PMA NumberP860022
Supplement NumberS049
Date Received12/22/1997
Decision Date02/06/1998
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Wester Australia 60017.
-
-