PMA P040046S021
- Device
- NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S021
- Product code
- FTR
- Decision date
- 2017-08-28
- 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 labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10%; (applicable to generic versions as well) from the patient and physician labeling, and 2) modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
Current openFDA PMA Record#
- Device
- NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S021
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-08-28
- Decision code
- APPR
- Date received
- 2017-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10%; (applicable to generic versions as well) from the patient and physician labeling, and 2) modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).