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510(k) Data Aggregation
K Number
K063091Device Name
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
Manufacturer
TYRX PHARMA, INC.
Date Cleared
2008-01-16
(463 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
TYRX PHARMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AIGISRx is intended to securely hold a pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body. AIGISRX contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in-vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.
Device Description
AIGISRX is a dual component (resorbable and non-resorbable), sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. AIGISRX is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer. AIGISRX bioresorbable polymer coating contains the antimicrobial agents, rifampin and minocycline in concentrations of 86 ug/cm2.
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