|Trade Name||SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY|
|Generic Name||saline-filled mammary prosthesis|
||General & Plastic Surgery
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) an increase in the thickness of the shell radius/base for style 5000pt and 2) a decrease in thickness of the textured layer from 0. 02" to 0. 01" for styles 5000, 5000pt, 6000 and 6000pt. The second change effectively withdraws the approved change in supplement 2.