RingJect and Capsular Tension Ring (CTR)

FDA Premarket Approval P030023 S008

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

DeviceRingJect and Capsular Tension Ring (CTR)
Generic NameRing, Endocapsular
ApplicantOPHTEC USA, INC.6421 Congress Ave., Suite 112boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-02-08
Decision Date2022-07-21
PMAP030023
SupplementS008
Product CodeMRJ 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressOPHTEC USA, INC.
6421 Congress Ave., Suite 112
boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change To The Processing Agent Used In The Milling Process For The Capsular Tension Ring (CTR) And RingJect

Supplemental Filings

Supplement NumberDateSupplement Type
P030023Original Filing
S008 2022-02-08 30-day Notice
S007 2018-12-18 30-day Notice
S006
S005 2016-06-10 30-day Notice
S004 2014-07-21 Normal 180 Day Track
S003
S002 2012-01-05 135 Review Track For 30-day Notice
S001 2011-10-19 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
08717819070286 P030023 004
08717819070279 P030023 004

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