Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: NATRELLE SALINE-FILLED BREAST IMPLANTS
• Classification Name: prosthesis, breast, inflatable, internal, saline
• Generic Name: silicone inflatable breast prosthesis
• Regulation Number: 878.3530
• Applicant: ALLERGAN
• PMA Number: P990074
• Supplement Number: S022
• Date Received: 10/14/2009
• Decision Date: 11/10/2009
• Product Code: FWM [ Registered Establishments with FWM ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in the expiration date of a raw material.