Health Medical Homework Help. Maricopa Community Colleges Novel Cardiac Catheter Summary
“Health Medical Homework Help”,
“text”: “Health Medical Homework Help. Maricopa Community Colleges Novel Cardiac Catheter Summary
Project: Create a Traditional 510(k) submission for a Cardiac Catheter with Clot Prevention Coating Predicate Device: Cardiac Catheter Modification: Clot Prevention Coating Description of the Predicate and Proposed Modification: To minimize the risk of restenosis after cardiac revascularization, drug-eluting stents (DES) used in cardiac catheters include a medication that is actively delivered at the stent insertion site. However, concerns have been raised about the safety of drug-eluting stents due to the possibility of blood clots developing between 6 and 12 months after implantation increasing the risk of a sudden heart attack (Lagerqvist et al., 2007). As a result, the primary benefit of the novel Cardiac Clot-Free Catheter Device is to reduce the risk of restenosis while not increasing the chance of a blood clot by implanting new sustained-release DES with a long-lasting coating. I am needing individual sections for the following: Declarations of conformity & summary reportProposed labelingSterilization/shelf life Please Note: Most of this information can be taken from the predicate device with minor modifications for cloth preventing coating. This is for a Class III device only I have attached some resources and the following are some FDA links that you might find helpful when researching: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/default.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm Additional Reference: References: Lagerqvist, B., James, S. K., Stenestrand, U., Lindbäck, J., Nilsson, T., Wallentin, L., & SCAAR Study Group (2007). Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. The New England journal of medicine, 356(10), 1009?1019. https://doi.org/10.1056/NEJMoa067722 Health Medical Homework Help”,
“url”: “/health-medical-homework-help-3720/”
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Project: Create a Traditional 510(k) submission for a Cardiac Catheter with Clot Prevention Coating
Predicate Device: Cardiac Catheter
Modification: Clot Prevention Coating
Description of the Predicate and Proposed Modification:
To minimize the risk of restenosis after cardiac revascularization, drug-eluting stents (DES) used in cardiac catheters include a medication that is actively delivered at the stent insertion site. However, concerns have been raised about the safety of drug-eluting stents due to the possibility of blood clots developing between 6 and 12 months after implantation increasing the risk of a sudden heart attack (Lagerqvist et al., 2007). As a result, the primary benefit of the novel Cardiac Clot-Free Catheter Device is to reduce the risk of restenosis while not increasing the chance of a blood clot by implanting new sustained-release DES with a long-lasting coating.
I am needing individual sections for the following:
Declarations of conformity & summary report
Proposed labeling
Sterilization/shelf life
Please Note: Most of this information can be taken from the predicate device with minor modifications for cloth preventing coating. This is for a Class III device only
I have attached some resources and the following are some FDA links that you might find helpful when researching:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/default.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Additional Reference:
References:
Lagerqvist, B., James, S. K., Stenestrand, U., Lindbäck, J., Nilsson, T., Wallentin, L., & SCAAR Study Group (2007). Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. The New England journal of medicine, 356(10), 1009?1019. https://doi.org/10.1056/NEJMoa067722
Health Medical Homework Help
