PMA P040046S013
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S013
- Product code
- FTR
- Decision date
- 2015-08-05
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES THAT INCLUDE: FOUR (4) SIZES OF STYLE FL 410; FOUR (4) SIZES OF STYLE ML 410; ONE (1) SIZE OF STYLE LM 410; THREE (3) SIZES OF STYLE LL 410; TWO (2) SIZES OF STYLE LF 410; FOUR (4) SIZES OF STYLE FX 410; FOUR (4) SIZES OF STYLE MX 410; AND SIX (6) SIZES OF STYLE LX 410. THESE TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES ENCOMPASS A RANGE OF: VOLUME = 140-775 CC; WIDTH = 9.5-15.5 CM; HEIGHT = 7.6-16.0 CM; AND PROJECTION = 2.9-7.1 CM.
Current openFDA PMA Record#
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S013
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-08-05
- Decision code
- APPR
- Date received
- 2014-12-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES THAT INCLUDE: FOUR (4) SIZES OF STYLE FL 410; FOUR (4) SIZES OF STYLE ML 410; ONE (1) SIZE OF STYLE LM 410; THREE (3) SIZES OF STYLE LL 410; TWO (2) SIZES OF STYLE LF 410; FOUR (4) SIZES OF STYLE FX 410; FOUR (4) SIZES OF STYLE MX 410; AND SIX (6) SIZES OF STYLE LX 410. THESE TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES ENCOMPASS A RANGE OF: VOLUME = 140-775 CC; WIDTH = 9.5-15.5 CM; HEIGHT = 7.6-16.0 CM; AND PROJECTION = 2.9-7.1 CM.