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.
Approval to replace the current deionized water system to a new reverse osmosis & deionized water system with new piping and fixtures. This change applies to the water system is being replaced by a new reverse osmosis & deionized water system with new piping and fixtures. The following manufacturing facility is affected by the change(s): orchid orthopedics solutions, 23149 commerce drive, farmington hills, mi 48335 usa.
Device | PRESTIGE LP Cervical Disc |
Generic Name | Prosthesis, Intervertebral Disc |
Applicant | Medtronic Sofamor Danek USA, Inc. |
Date Received | 2020-10-21 |
Decision Date | 2020-12-01 |
PMA | P090029 |
Supplement | S015 |
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 | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
Supplement Number | Date | Supplement Type |
---|---|---|
P090029 | Original Filing | |
S015 | 2020-10-21 | 30-day Notice |
S014 | 2020-03-18 | 30-day Notice |
S013 | 2019-09-26 | Normal 180 Day Track No User Fee |
S012 | 2019-05-23 | Normal 180 Day Track No User Fee |
S011 | 2018-10-31 | Normal 180 Day Track No User Fee |
S010 | 2018-09-18 | Special (immediate Track) |
S009 | 2017-12-11 | Normal 180 Day Track No User Fee |
S008 | 2017-07-13 | Normal 180 Day Track No User Fee |
S007 | 2016-12-22 | Normal 180 Day Track |
S006 | 2016-08-05 | Normal 180 Day Track No User Fee |
S005 | 2016-07-11 | 30-day Notice |
S004 | 2015-09-02 | Normal 180 Day Track No User Fee |
S003 | 2015-06-03 | Panel Track |
S002 | 2014-08-22 | Normal 180 Day Track No User Fee |
S001 | 2014-08-08 | Normal 180 Day Track No User Fee |