PMA P990033S016
- Device
- PEPGEN P-15 FLOW
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S016
- Product code
- NPZ
- Decision date
- 2009-12-09
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- CHANGE OF THE IN-PROCESS BIOBURDEN SPECIFICATION.
Current openFDA PMA Record#
- Device
- PEPGEN P-15 FLOW
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S016
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2009-12-09
- Decision code
- OK30
- Date received
- 2009-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF THE IN-PROCESS BIOBURDEN SPECIFICATION.