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 of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p200022.
|Device||Simplify Cervical Artificial Disc|
|Generic Name||Prosthesis, Intervertebral Disc|
|Applicant||Simplify Medical, Inc.|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol - Ode/oir|
|Applicant Address||Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085|
|Supplement Number||Date||Supplement Type|
|S002||2020-10-07||Normal 180 Day Track No User Fee|