# Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/modifications-to-devices-subject-to-premarket-approval-pma-the-pma-supplement-decision-making-process-guidance-for-industry-and-fda-staff/2fa147f5-4cd9-4ac0-9ae1-09b62dffa25e

> FDA guidance document: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process:  Guidance for Industry and FDA Staff. Issue date: December 11, 2008. Get complete insights and analysis.

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## Details

- Title: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2008-12-11
- Last Changed: 2022-02-08
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2007-D-0025">FDA-2007-D-0025</a>

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