PMA supplement
P860005 S009: PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
FDA PMA supplement · Normal 180 Day Track · Interpore Intl.
Key facts
| Original PMA | P860005 |
|---|---|
| Supplement number | S009 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES |
| Generic name | Filler, bone void, non-osteoinduction |
| Applicant | Interpore Intl. |
| Product code | MBS |
| Received date | Oct 27, 1997 |
| Decision date | Apr 28, 1998 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: