HDE supplement
H010002 S007: OP-1 IMPLANT
FDA HDE supplement · special (immediate track) · OLYMPUS BIOTECH CORPORATION
Key facts
| Original HDE | H010002 |
|---|---|
| Supplement number | S007 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | OP-1 IMPLANT |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
| Applicant | OLYMPUS BIOTECH CORPORATION |
| Product code | MPW |
| Received date | May 2, 2003 |
| Decision date | Jul 10, 2003 |
| Docket number | 01M-0482 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: