FDA guidance
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh…
FDA guidance · Final · issued Mar 1, 1999
Key facts
| Title | Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance |
|---|---|
| Status | Final |
| Issue date | Mar 1, 1999 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Medical Devices |
| Docket number | FDA-2020-D-0957 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 1–9 Product codes referenced
- 1–9 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents