PMA supplement
P030032 S001: HYLAFORM PLUS (HYLAN B GEL)
FDA PMA supplement · Panel Track · Genzyme Biosurgery
Key facts
| Original PMA | P030032 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | HYLAFORM PLUS (HYLAN B GEL) |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Genzyme Biosurgery |
| Product code | LMH |
| Received date | Jun 22, 2004 |
| Decision date | Oct 13, 2004 |
| Docket number | 04M-0467 |
| Notice date | Oct 27, 2004 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: