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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DevicePCM CERVICAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantNUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121
PMA NumberP100012
Supplement NumberS002
Date Received01/22/2013
Decision Date03/29/2013
Withdrawal Date 04/22/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE PATIENT BROCHURE.
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