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Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.

Bibliographic Details
Corporate Authors: Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: [Silver Spring, Md.] : [Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Center for Biologics Evaluation and Research, [2008]
Subjects:
Medical instruments and apparatus > Testing.
Online Access:https://purl.fdlp.gov/GPO/LPS110580
Description
Item Description:Title from PDF title page (viewed on Mar. 24, 2009).
"December 11, 2008."
Electronic resource.
Physical Description:25 pages : digital, PDF file.
Format: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.