PMA P020056S019
- Device
- SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S019
- Product code
- FTR
- Decision date
- 2013-03-27
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGE THE CURRENT SOAKING METHOD FROM A MANUAL TO AN AUTOMATIC PROCESS DURING THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S019
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2013-03-27
- Decision code
- OK30
- Date received
- 2013-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE CURRENT SOAKING METHOD FROM A MANUAL TO AN AUTOMATIC PROCESS DURING THE MANUFACTURING PROCESS.