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.
Update to an existing holding fixture.
Device | PRODISC-C TOTAL DISC REPLACEMENT |
Classification Name | Prosthesis, Intervertebral Disc |
Generic Name | Prosthesis, Intervertebral Disc |
Applicant | Centinel Spine, LLC |
Date Received | 2010-06-07 |
Decision Date | 2010-07-02 |
PMA | P070001 |
Supplement | S008 |
Product Code | MJO |
Advisory Committee | Orthopedic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380 |
Supplement Number | Date | Supplement Type |
---|---|---|
P070001 | Original Filing | |
S021 | 2021-09-21 | 30-day Notice |
S020 | 2021-01-28 | 30-day Notice |
S019 | ||
S018 | 2019-06-21 | Normal 180 Day Track No User Fee |
S017 | 2018-12-04 | Normal 180 Day Track No User Fee |
S016 | 2017-09-20 | 30-day Notice |
S015 | 2017-06-30 | 30-day Notice |
S014 | ||
S013 | 2014-04-03 | 135 Review Track For 30-day Notice |
S012 | 2012-03-13 | 135 Review Track For 30-day Notice |
S011 | 2011-07-19 | 30-day Notice |
S010 | 2011-07-18 | 135 Review Track For 30-day Notice |
S009 | 2010-08-02 | Real-time Process |
S008 | 2010-06-07 | 30-day Notice |
S007 | 2010-06-02 | 30-day Notice |
S006 | 2010-05-27 | 30-day Notice |
S005 | 2010-05-27 | 135 Review Track For 30-day Notice |
S004 | 2010-05-19 | Normal 180 Day Track No User Fee |
S003 | ||
S002 | 2008-03-12 | Normal 180 Day Track No User Fee |
S001 | 2008-01-31 | Real-time Process |