NATRELLE SILICONE-FILLED BREAST IMPLANT
FDA premarket approval P020056/S003 · decided 2007-05-17
Approval details
- PMA number
- P020056
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NATRELLE SILICONE-FILLED BREAST IMPLANT
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Allergan
- Date received
- 2007-02-26
- Decision date
- 2007-05-17
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SILICONE-FILLED BREAST IMPLANTS TO NATRELLE SILICONE-FILLED BREAST IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SILICONE-FILLED BREAST IMPLANTS AND IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF
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510(k) clearances by this applicant
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