A response to "major Complications Associated with Xenograft Biologic Mesh Implantation in Abdominal Wall Reconstructiong" (Harth KC, Rosen MJ. surg innov. 2009;16:324-329) and discussion of the MAUDE (Manufacturer and User Facility Device Experience) database, FDA regulation of biologic implants, and evidence-based medicine

Surgical Innovation

Volumn 17, Issue 3, 2010, Pages 273-275

  Segan, Ross David ^a  

^a MEDTRONIC INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMATERIAL;

ABDOMINAL WALL CLOSURE; ABDOMINOPLASTY; BIOMEDICAL TECHNOLOGY ASSESSMENT; DATA BASE; FOOD AND DRUG ADMINISTRATION; LETTER; PATIENT SAFETY; SURGICAL EQUIPMENT; XENOGRAFT;

ABDOMINAL WALL; DATABASES AS TOPIC; HUMANS; RECONSTRUCTIVE SURGICAL PROCEDURES; SURGICAL MESH; TRANSPLANTATION, HETEROLOGOUS;

EID: 77956253036     PISSN: 15533506     EISSN: None     Source Type: Journal    
DOI: 10.1177/1553350610371214     Document Type: Letter

References (5)

1. 21 CFR 800-1299.
2. 21 CFR 878.3300.
3. 21 USC 360(k); 21 CFR ?§ 807.81 et seq.
4. 21 CFR 1270-1.
5. 21 CFR 812.