PMA P020056S040
- Device
- NATRELLE Silicon-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S040
- 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 Silicon-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S040
- 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).