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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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Applicant
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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medtronic synchromed infusion system MEDTRONIC Inc. P860004S040 04/13/1998
scimed rebel ptca catheter SCIMED LIFE SYSTEMS, INC. P860019S137 04/15/1998
dermagraft-tc(tm) SHIRE REGENERATIVE MEDICINE P960007S007 05/29/1998
acs rx comet vp (tm) coronary dilatation catheter/hydrocoat hydrophilic ADVANCED CARDIOVASCULAR SYSTEMS, INC. P810046S185 06/08/1998
hydrasoft, hydrasoft toric, hydrasoft xw and hydrasoft toric xw (methalicon b) soft (hydrophilic) contact lenses COOPERVISION, INC. P850079S029 07/02/1998
cook chorionic villus sampling set Cook Incorporated P900007S001 07/08/1998
carpentier-edwards bioprosthetic valved conduit EDWARDS LIFESCIENCES, LLC. P870056S006 08/07/1998
medtronic freestyle aortic root bioprosthesis Medtronic, Inc. P970031S004 09/18/1998
phylax implantable cardioverter defibrillator system BIOTRONIK, INC. P980023 10/27/1998
poly-safe(tm) a-track(tm) pacing leads CARDIAC CONTROL SYSTEMS, INC. P890039S016 11/09/1998

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