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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.
 
DeviceCalcivis Imaging System
Generic NameCaries detection product with drug or biologic
ApplicantCalcivis Limited
Nine Edinburgh Bioquarter 9 Little France Rd.
Edinburgh 
PMA NumberP170029
Supplement NumberS001
Date Received03/21/2023
Decision Date03/23/2023
Product Code QJX 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replace the drug substance manufacturing wash step buffer component of Triton X-100 with Ecosurf SA-9 at the 3P Biopharmaceuticals facility located in Navarra, Spain.
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