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. |
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Device | PRODISC L TOTAL DISC REPLACEMENT |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 |
PMA Number | P050010 |
Supplement Number | S006 |
Date Received | 04/26/2010 |
Decision Date | 05/26/2010 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPGRADE OF THE ROFIN BAASEL SOFTWARE, WHICH CONTROLS THE ETCHING MACHINE, FROM VERSION 1.0.54 TO 1.0.61. |
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