PMA P990033S002

Device: PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY)
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S002
Product code: NPZ
Decision date: 2001-08-09
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR A MODIFICATION TO PEPGEN P-15 TO FORM PEPGEN P-15 PUTTY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PEPGEN P-15 FLOW, BUT HAVE THE SAME INDICATIONS FOR USE AS PEPGEN P-15.

Current openFDA PMA Record#

Device: PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY)
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S002
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2001-08-09
Decision code: APPR
Date received: 2001-01-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFICATION TO PEPGEN P-15 TO FORM PEPGEN P-15 PUTTY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PEPGEN P-15 FLOW, BUT HAVE THE SAME INDICATIONS FOR USE AS PEPGEN P-15.