PMA P990033S007

Device: PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S007
Product code: NPZ
Decision date: 2006-06-06
Generic name: Bone grafting material, dental, with biologic component
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.

Current openFDA PMA Record#

Device: PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S007
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2006-06-06
Decision code: APPR
Date received: 2006-05-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.