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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 6-353
Standard
ASTM F2051-00 (Reapproved 2014)
Standard Specification for Implantable Saline Filled Breast Prosthesis
Scope/Abstract
1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast.

1.2 Limitations:

1.2.1 This specification does not cover custom fabricated implantable breast prostheses.

1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F703.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§878.3530 Prosthesis, Breast, Inflatable, Internal, Saline Class 3 FWM
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 George Ngatha
  FDA/OMPT/CDRH/OC/DMQ/ASDB/
  301-796-6444
  george.ngatha@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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