PMA P990033S015
- Device
- PEPGEN 15
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S015
- Product code
- NPZ
- Decision date
- 2008-01-11
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIGENICS US, INC, GURNEE, ILLINOIS.
Current openFDA PMA Record#
- Device
- PEPGEN 15
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S015
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2008-01-11
- Decision code
- APPR
- Date received
- 2007-08-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIGENICS US, INC, GURNEE, ILLINOIS.