PMA P040046S016
- Device
- NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S016
- Product code
- FTR
- Decision date
- 2016-08-17
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for changes to the presentation format of the indication-specific brochures and mini-brochure.
Current openFDA PMA Record#
- Device
- NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S016
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-08-17
- Decision code
- APPR
- Date received
- 2016-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the presentation format of the indication-specific brochures and mini-brochure.