Aesculap activL Artificial Disc

FDA Premarket Approval P120024 S011

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.

Pre-market Approval Supplement Details

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.

DeviceAesculap activL Artificial Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantAESCULAP IMPLANT SYSTEMS, LLC
Date Received2019-12-06
Decision Date2020-01-31
PMAP120024
SupplementS011
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway center Valley, PA 18034

Supplemental Filings

Supplement NumberDateSupplement Type
P120024Original Filing
S011 2019-12-06 Normal 180 Day Track No User Fee
S010
S009
S008 2019-03-29 Real-time Process
S007 2017-11-06 135 Review Track For 30-day Notice
S006
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
S002 2015-08-07 Real-time Process
S001 2015-07-24 Real-time Process

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