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510(k) Data Aggregation
K Number
K082276Device Name
SYNTHEMED DEVICE
Manufacturer
SYNTHEMED, INC.
Date Cleared
2008-11-18
(99 days)
Product Code
LYA
Regulation Number
874.4780Why did this record match?
Applicant Name (Manufacturer) :
SYNTHEMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces.
Device Description
The SyntheMed Device ("the device") is a single use, synthetic, bioresorbable polymeric film composed of polymers used extensively in implantable, absorbable medical devices. The device comprises bis(hydroxyl)-terminated PLA-PEG-PLA triblocks, where PLA = poly(lactic acid) and PEG = poly(ethylenc glycol). These PLA-PEG-PLA triblocks are chain extended to yicld the device's final high molecular weight polymer. This device functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. The device leaves the site of placement by natural elimination within 4 weeks, or it may be aspirated from the cavity earlier at the discretion of the physician.
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