Approval for the addition of the information regarding the safety of the device during mri exposure to the patient information booklet.
Device | IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X |
Classification Name | Telescope, Implantable, Miniature |
Generic Name | Telescope, Implantable, Miniature |
Applicant | VISIONCARE, INC. |
Date Received | 2011-12-27 |
Decision Date | 2012-02-23 |
PMA | P050034 |
Supplement | S006 |
Product Code | NCJ |
Advisory Committee | Ophthalmic |
Supplement Type | Real-time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | VISIONCARE, INC. 14395 Saratoga Avenue #150 saratoga, CA 95070 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P050034 | | Original Filing |
S020 |
2018-09-11 |
Normal 180 Day Track No User Fee |
S019 |
2017-09-21 |
30-day Notice |
S018 | | |
S017 |
2016-09-26 |
30-day Notice |
S016 |
2016-09-23 |
Real-time Process |
S015 |
2014-11-28 |
Normal 180 Day Track No User Fee |
S014 |
2014-06-11 |
Real-time Process |
S013 |
2013-12-26 |
Normal 180 Day Track |
S012 |
2013-12-12 |
30-day Notice |
S011 |
2013-08-08 |
30-day Notice |
S010 |
2013-07-16 |
30-day Notice |
S009 |
2013-05-15 |
Normal 180 Day Track No User Fee |
S008 |
2012-12-20 |
30-day Notice |
S007 |
2012-12-04 |
30-day Notice |
S006 |
2011-12-27 |
Real-time Process |
S005 |
2011-03-02 |
30-day Notice |
S004 |
2010-12-15 |
Real-time Process |
S003 |
2010-09-29 |
30-day Notice |
S002 |
2010-08-30 |
Normal 180 Day Track No User Fee |
S001 |
2010-08-30 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices