PMA P040046S008
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S008
- Product code
- FTR
- Decision date
- 2014-11-07
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR ADDITIONAL NATRELLE 410 DEVICE STYLES AND SIZES INCLUDING: ONE (1) SIZE OF STYLE FL 410; ONE (1) SIZE OF STYLE ML 410; TWO (2) SIZES OF STYLE LL 410; FOUR (4) SIZES OF STYLE LM 410; TEN (10) SIZES OF STYLE LF 410; NINE (9) SIZES OF STYLE FX 410; NINE (9) SIZES OF STYLE MX 410; AND SEVEN (7) SIZES OF STYLE LX 410.
Current openFDA PMA Record#
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S008
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-11-07
- Decision code
- APPR
- Date received
- 2014-08-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDITIONAL NATRELLE 410 DEVICE STYLES AND SIZES INCLUDING: ONE (1) SIZE OF STYLE FL 410; ONE (1) SIZE OF STYLE ML 410; TWO (2) SIZES OF STYLE LL 410; FOUR (4) SIZES OF STYLE LM 410; TEN (10) SIZES OF STYLE LF 410; NINE (9) SIZES OF STYLE FX 410; NINE (9) SIZES OF STYLE MX 410; AND SEVEN (7) SIZES OF STYLE LX 410.