ACTIVL ARTIFICIAL DISC

Prosthesis, Intervertebral Disc

FDA Premarket Approval P120024 S002

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 for changes to the activl® artificial disc labeling that proposed changes to the instructions for use, surgical technique, patient brochure, and package label to reflect the mr testing that was conducted.

DeviceACTIVL ARTIFICIAL DISC
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantAESCULAP IMPLANT SYSTEMS, LLC
Date Received2015-08-07
Decision Date2015-11-04
PMAP120024
SupplementS002
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
S012 2022-06-13 30-day Notice
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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