|
Device | PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT |
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 | S007 |
Date Received | 05/22/2006 |
Decision Date | 06/06/2006 |
Withdrawal Date
|
02/16/2016 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE CHANGE IN INDICATION FOR USE - THE DEVICE IS NO LONGER INTENDED FOR REUSE AFTER RESTERILIZATION AND WILL BE LABELED AS A SINGLE USE ONLY DEVICE. |