- Device
- PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)
- Applicant
- Interpore Intl.
- PMA number
- P860005
- Supplement
- S008
- Product code
- MBS
- Generic name
- Filler, bone void, non-osteoinduction
- Decision date
- 1997-09-11
- Decision code
- APPR
- Date received
- 1997-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new sterilization site located at Isomedix Operations, Inc., Sand Utah Division, 9120 South 150 East, Sandy, UT.