PMA P990033S001
- Device
- PEPGEN-P15
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S001
- Product code
- NPZ
- Decision date
- 2000-01-27
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- Approval is for a new sterilization facility located at STERIS-Isomedix Services, 9120 South 150 East, Sandy, Utah.
Current openFDA PMA Record#
- Device
- PEPGEN-P15
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S001
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2000-01-27
- Decision code
- APPR
- Date received
- 1999-11-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval is for a new sterilization facility located at STERIS-Isomedix Services, 9120 South 150 East, Sandy, Utah.