Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process
- Additional Titles:
- At head of title: Guidance for industry and FDA staff
- [Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; [Rockville, Md.] : Center for Biologics Evaluation and Research, 
- Physical Description:
- 25 pages : digital, PDF file
- Additional Creators:
- Center for Devices and Radiological Health (U.S.) and Center for Biologics Evaluation and Research (U.S.)
- Restrictions on Access:
- Free-to-read Unrestricted online access
- Title from PDF title page (viewed on Mar. 24, 2009). and "December 11, 2008."
- Technical Details:
- Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/cdrh/ode/guidance/1584.pdf ; current access is available via PURL.
View MARC record | catkey: 5201323