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. |
|
Device | 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 | S016 |
Date Received | 11/09/2009 |
Decision Date | 12/09/2009 |
Withdrawal Date
|
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 | Yes |
Approval Order Statement CHANGE OF THE IN-PROCESS BIOBURDEN SPECIFICATION. |
|
|