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Surgical specialties / Plastic surgery / Collagen / Artelon / Rotator cuff / Surgical suture / Incisional hernia / Tissue engineering / Rotator cuff tear / Medicine / Biology / Shoulder


Attachment G Predicate Device Comparison Table Device Name RestoreĀ® Orthobiologic
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Company

Device Name SurgiSisTM Sling Sponsor Cook Biotech Inc / OptiMeshTM Sponsor Tissue Science Laboratories PLC / SIS Plastic Surgery Matrix Sponsor Cook Biotech Inc / Kensey Nash Corp. / TissueMend Sponsor Kensey Nash Corp. / Dermal Collagen Surgical Mesh Sponsor Cook Biotech Inc. / Soft Tissue Implant BioBlanket Surgical Mesh DePuy Inc. / Cook Biotech Inc. / Device Senmed Medical Ventures SurgiSis Cook Biotech Inc. / DePuy Inc. / PLC Tissue Science Laboratories PLC / /

IndustryTerm

stainless steel / subject devices / manufacturing processes / /

MedicalCondition

urethral and vaginal prolapse / intrinsic sphincter deficiency / rectal and vaginal prolapse / urinary incontinence / colon and rectal prolapse / rectocele / hernia / e.g. tumor / rectal intussusception / vaginal prolapse / /

MedicalTreatment

lobectomy / repair surgery / gastric banding / rotator cuff repair surgery / rotator cuff repair / incisions / soft tissue repair / Reconstructive Surgery / gastric bypass / rotator cuff surgery / plastic and reconstructive surgery / segmentectomy / /

Organization

office of Compliance / FDA / Inc. Tissue Science Lab / /

Position

physician / /

Product

Harman On Time Radio / /

URL

http /

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