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.
 
DeviceVISIONCARE IMPLANTABLE MINIATURE TELESCOPE
Generic NameTelescope, implantable, miniature
ApplicantSamsara Vision, Inc.
27 Us Hwy. 202, Suite 8/9
Far Hills, NJ 07931
PMA NumberP050034
Supplement NumberS015
Date Received11/28/2014
Decision Date01/27/2015
Product Code NCJ 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY PROTOCOL: UPDATED STUDY PROTOCOL WITH THE INCLUSION OF CASE REPORT FORM (CRF) AND STUDY TIMELINE.
-
-