KAMRA INLAY

FDA Premarket Approval P120023 S004

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.

Pre-market Approval Supplement Details

Approval of the protocol for the post-approval study (pas) protocol.

DeviceKAMRA INLAY
Generic NameImplant, Corneal, Refractive
ApplicantCorneaGen
Date Received2016-09-28
Decision Date2017-05-16
PMAP120023
SupplementS004
Product CodeLQE 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address CorneaGen 1200 6th Avenue suite 300 seattle, WA 98101

Supplemental Filings

Supplement NumberDateSupplement Type
P120023Original Filing
S005 2017-01-25 Normal 180 Day Track No User Fee
S004 2016-09-28 Normal 180 Day Track No User Fee
S003
S002 2015-10-28 Normal 180 Day Track
S001 2015-05-18 Normal 180 Day Track No User Fee

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