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 | PEPGEN P-15/PEPGEN P-15 FLOW |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | CERAMED CORP. 12860 WEST CEDAR DRIVE, SUITE 108 LAKEWOOD, CO 80228 |
PMA Number | P990033 |
Supplement Number | S003 |
Date Received | 01/14/2002 |
Decision Date | 01/25/2002 |
Withdrawal Date
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02/16/2016 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN MANUFACTURER/VENDOR FOR THE P-15 PEPTIDE. |
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