- Device
- PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
- Applicant
- Interpore Intl.
- PMA number
- P860005
- Supplement
- S011
- Product code
- MBS
- Generic name
- Filler, bone void, non-osteoinduction
- Decision date
- 1999-05-25
- Decision code
- APPR
- Date received
- 1999-04-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling that reflects the results of the completed post-market approval study.