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U.S. Department of Health and Human Services

Premarket Approval - PMA

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Device Name
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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ventritex icd's using model 3307, v2.1a programmer software Abbott Medical P910023S051 03/02/2001
dema, diva and afm pulse generators MEDTRONIC Inc. P990001S006 03/07/2001
floseal(r) matrix/proceed(tm) hemostatic sealant BAXTER HEALTHCARE CORP. P990009S005 03/15/2001
nidek ec-5000 excimer laser system NIDEK CO., LTD. P970053S005 03/15/2001
sjm mechanical heart valve, master series coated aortic valved graft Abbott Medical P810002S055 03/16/2001
visx star s2/s3 excimer laser system AMO Manufacturing USA, LLC P930016S013 03/19/2001
rotablator(r) rotalink rotational angioplasty system and rotalink(tm) plus with exchangeable catheter Boston Scientific Corp. P900056S060 03/21/2001
vascular solutions duett model 1000 sealing device Vascular Solutions, Inc. P990037S003 03/22/2001
mcghan saline-filled breast implants Allergan P990074S005 04/09/2001
acuvue 2 colors brand (etafilcon a) contact lens with uv blocker VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. N18033S035 04/12/2001

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