PMA P990033S017
- Device
- PEPGEN P-15 FLOW
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S017
- Product code
- NPZ
- Decision date
- 2010-07-20
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- USE OF AN ALTERNATE FOIL POUCH SUPPLIER AND ALTERNATE AUTOCLAVE STERILIZER.
Current openFDA PMA Record#
- Device
- PEPGEN P-15 FLOW
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S017
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2010-07-20
- Decision code
- OK30
- Date received
- 2010-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE FOIL POUCH SUPPLIER AND ALTERNATE AUTOCLAVE STERILIZER.