PMA P020056S034
- Device
- NATRELLE SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S034
- Product code
- FTR
- Decision date
- 2016-09-22
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for Inspira Cohesive Silicone-Filled Breast Implants filled with highly cohesive silicone gel.
Current openFDA PMA Record#
- Device
- NATRELLE SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S034
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-09-22
- Decision code
- APPR
- Date received
- 2016-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Inspira Cohesive Silicone-Filled Breast Implants filled with highly cohesive silicone gel.