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 forfollowing changes to the activl® artificial disc enhanced safety surveillance survey:1) section: pain management; question 4: add n/a checkbox to the column, using spike endplate as now it is possible that a surgeon implanters experience would exclude the spike endplate and only include the keel endplate;2) section: spike vs. Keel endplate design; headerremove for surgeons outside the us only as now it is possible that a surgeon implanter within the u. S. Will have the option of the spike endplate and keel endplate. The following change to the aesculap activl® artificial disc enhanced safety surveillance study as follows:3) appendix aremove previous version of the activl® artificial disc enhanced safety surveillance survey and replaced it with the updated version reflecting the updates detailed above.
|Device||Aesculap activL Artificial Disc|
|Generic Name||Prosthesis, Intervertebral Disc|
|Applicant||AESCULAP IMPLANT SYSTEMS, LLC|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol - Ode/oir|
|Applicant Address||AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway center Valley, PA 18034|
|Supplement Number||Date||Supplement Type|
|S011||2019-12-06||Normal 180 Day Track No User Fee|
|S007||2017-11-06||135 Review Track For 30-day Notice|
|S005||2017-02-24||Normal 180 Day Track No User Fee|
|S004||2016-12-23||Normal 180 Day Track|
|S003||2015-11-18||Normal 180 Day Track No User Fee|