PMA P990033S004

Device: PEPGEN P-15 AND PEPGEN P-15 FLOW
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S004
Product code: NPZ
Decision date: 2002-06-14
Generic name: Bone grafting material, dental, with biologic component
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.

Current openFDA PMA Record#

Device: PEPGEN P-15 AND PEPGEN P-15 FLOW
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S004
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2002-06-14
Decision code: APPR
Date received: 2002-04-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.