MEMORYGEL BREAST IMPLANT
FDA premarket approval P030053/S019 · decided 2015-01-16
Approval details
- PMA number
- P030053
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MEMORYGEL BREAST IMPLANT
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Mentor Corp.
- Date received
- 2014-08-04
- Decision date
- 2015-01-16
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.
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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 |