MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
FDA premarket approval P030053 · decided 2006-11-17
Approval details
- PMA number
- P030053
- Trade name
- MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Mentor Corp.
- Date received
- 2003-12-12
- Decision date
- 2006-11-17
- Days to decision
- 1071 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR THE MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS. THIS DEVICE 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 A PRIMARY BREAST AUGMENTATION SURGERY. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813) | Mentor Corp. | 2013-04-11 |
| MENTOR NOVASILK MESH (K053414) | Mentor Corp. | 2005-12-27 |
| MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K050008) | Mentor Corp. | 2005-06-03 |
| MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (K042851) | Mentor Corp. | 2004-11-09 |
| MENTOR GENESIS PENILE PROSTHESIS (K040959) | Mentor Corp. | 2004-10-29 |
| MENTOR OBTAPE TRANS-OBTURATOR TAPE (K031767) | Mentor Corp. | 2003-07-17 |
| MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY (K011493) | Mentor Corp. | 2002-10-01 |
| MENTOR CONTOUR PROFILE TISSUE EXPANDER (K011500) | Mentor Corp. | 2001-12-03 |