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Record Nr. |
UNINA9910698835203321 |
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Titolo |
Premarket approval application modular review [[electronic resource]] |
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Pubbl/distr/stampa |
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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, , [2003] |
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Descrizione fisica |
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14 pages : digital, PDF file |
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Soggetti |
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Medical instruments and apparatus - Evaluation - Government policy - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Title from PDF title page (viewed on May 22, 2009). |
"Document issued on: November 3, 2003". |
"Supersedes and replaces " A modular approach to PMA review ", dated January 29, 1998, and "Guidance for the medical device industry on PMA shell development and modular review", dated November 6, 1998". |
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