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City Rancho Cordova / / Company Ethicon Inc. / AMES / Contact ThermoGenesis Corp. / ThermoGenesis Corp. / / Country Taiwan / Saudi Arabia / Mexico / Colombia / Russia / Brazil / China / Israel / Argentina / / Event FDA Phase / / IndustryTerm treatment / medical devices / control / plasma processing disposable / absorbable hemostatic device / plasma processing / upright floor-model device / cryoprecipitate solution / thrombin solution / sterile docking device / ml thrombin containing solution / thrombin solutions / / MedicalCondition skin disorder / disseminated intravascular coagulation / herpes zoster / arthritis / sickle cell anemia / Waldenstrom's macroglobulinemia / multiple myeloma / urinary incontinence / cellulitis / cerebrovascular accident / ventricular extrasystoles / nausea / cirrhosis / glycosuria / hemoptysis / conjunctivitis / gastrointestinal disorder / withdrawal syndrome / bradycardia / polyuria / pulmonary embolus / constipation / alkalosis / afibrinogenemia / acquired hematologic/coagulation disorders / Back Pain / rectal disorder / respiratory disorder / abdominal pain / congestive heart failure / hypertension / hemophilia A / accidental injury / hypothyroidism / hyperphosphatemia / chills / shock / hypophosphatemia / ThermoGenesis Corp. CryoSeal FS System PMA BP060001 disorders / hemophilia B / vertigo / paresthesia / peripheral neuritis / AV block / hyperlipidemia / fever / pain / maculopapular rash / injection site inflammation / von Willebrand disease / Migraine Nausea / anemia / hypercholesterolemia / abscess / disorders / / MedicalTreatment trauma surgeries / Liver surgery / surgery / drainage / / Organization European Union / / Person Achieving Hemostasis Time / / Product FS / Agitation Anorexia Chest Pain Ileus Injection / coumadin / Calcium Chloride / BP060001 / CryoSeal FS System / / ProvinceOrState South Dakota / California / / Technology heat transfer / radio frequency / /
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA