PMA P040046S005
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE- FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S005
- Product code
- FTR
- Decision date
- 2014-09-19
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR LABELING DOCUMENTS FOR THE NATRELLE® 410 HIGHLY COHESIVEANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS CONTAINING 10-YEAR DATA FROM THE FINAL POSTAPPROVAL STUDY REPORT.
Current openFDA PMA Record#
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE- FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S005
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-09-19
- Decision code
- APPR
- Date received
- 2014-01-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR LABELING DOCUMENTS FOR THE NATRELLE® 410 HIGHLY COHESIVEANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS CONTAINING 10-YEAR DATA FROM THE FINAL POSTAPPROVAL STUDY REPORT.