PMA P990033S005

Device: PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S005
Product code: NPZ
Decision date: 2004-03-15
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR: 1) THE ADDITION OF A PASTE FORM OF PEPGEN P-15, 2) MODIFICATION OF THE DEVICE LABELING FOR ALL PEPGEN P-15 DEVICES, AND 3) CHANGING OF THE CONTRACT MANUFACTURER FOR THE DEVICE CARRIER TO HYALURON, INC., WOBURN, MASSACHUSETTS.

Current openFDA PMA Record#

Device: PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S005
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2004-03-15
Decision code: APPR
Date received: 2003-11-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) THE ADDITION OF A PASTE FORM OF PEPGEN P-15, 2) MODIFICATION OF THE DEVICE LABELING FOR ALL PEPGEN P-15 DEVICES, AND 3) CHANGING OF THE CONTRACT MANUFACTURER FOR THE DEVICE CARRIER TO HYALURON, INC., WOBURN, MASSACHUSETTS.