| ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 6-353 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | George Ngatha FDA/OMPT/CDRH/OC/DMQ/ASDB/ 301-796-6444 george.ngatha@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.3530 | Prosthesis, Breast, Inflatable, Internal, Saline | Class 3 | FWM |
| There is no relevant guidance developed at this time. |