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 AND 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 | S004 |
Date Received | 04/22/2002 |
Decision Date | 06/14/2002 |
Withdrawal Date
|
02/16/2016 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATIONS FOR USE; AUGMENTATION OF BONY DEFECTS OF THE ALVEOLAR RIDGE, FILLING TOOTH EXTRACTION SITES, AND SINUS ELEVATION GRAFTING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PEPGEN P-15 AND PEPGEN P-15 FLOW. |
|
|