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Posted On: 12/10/2023 1:30:15 PM
Post# of 590
Not professing to be an expert in PMA or any FDA submission protocol but...
Bicompatability in hemostasis "STAR" submitted applications is important IMO so I investigated and came across the following if you are interested?
Novel research proposes hemostatic agents with antibacterial properties that demonstrate excellent biocompatibility while retaining rapid hemostasis.
https://www.rimsys.io/blog/your-estar-submiss...da-experts
Q: " Under Biocompatibility any idea when there will be endpoint questions for hemocompatibility or coagulation? Hemocompatibility endpoint information, including Hemolysis, Complement Activation, and Thrombogenicity information, will appear depending on the tissue contact type and duration you choose. If you choose Implant Device >30 days, you will see this tab appear for example. The tabs that show are based on our Biocompatibility guidance." Soooo the UEEC bell went off in my head! Is the company PMA application a perfect selection for the new STAR FDA submission method? YES! IMO FWIW
$5-$10+
Bicompatability in hemostasis "STAR" submitted applications is important IMO so I investigated and came across the following if you are interested?
Novel research proposes hemostatic agents with antibacterial properties that demonstrate excellent biocompatibility while retaining rapid hemostasis.
https://www.rimsys.io/blog/your-estar-submiss...da-experts
Q: " Under Biocompatibility any idea when there will be endpoint questions for hemocompatibility or coagulation? Hemocompatibility endpoint information, including Hemolysis, Complement Activation, and Thrombogenicity information, will appear depending on the tissue contact type and duration you choose. If you choose Implant Device >30 days, you will see this tab appear for example. The tabs that show are based on our Biocompatibility guidance." Soooo the UEEC bell went off in my head! Is the company PMA application a perfect selection for the new STAR FDA submission method? YES! IMO FWIW
$5-$10+
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