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FDA Device Info: PMA Historical Guidance Documents
FDA Device Info: PMA Historical Guidance Documents
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Historical guidance documents: (1) 1998, entitled "Modifications To Devices Subject to Premarket Approval – The PMA Supplement Decision Making Process" (2) 1986, entitled "Premarket Notification Review Program," 510(k) Memorandum K86-3, dated June 30, 1986
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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