PMA P990033S008

Device: PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S008
Product code: NPZ
Decision date: 2006-10-05
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, US, LLC, QUEENSBURY, NEW YORK, TO PERFORM THE ETHYLENE OXIDE STERILIZATION.

Current openFDA PMA Record#

Device: PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT
Applicant: Ceramed Corp.
PMA number: P990033
Supplement: S008
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2006-10-05
Decision code: APPR
Date received: 2006-08-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, US, LLC, QUEENSBURY, NEW YORK, TO PERFORM THE ETHYLENE OXIDE STERILIZATION.