Product Code: FTR

Products Classified as FTR

5530

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled

Silicone Gel-filled Breast Prosthesis.

Total Product Life Cycle (TPLC) Devices

5530

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled

Silicone Gel-filled Breast Prosthesis.

FDA Consensus Standards

• Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled [37532]: 21 CFR §878.3540 🔎

Pre-market Approvals for FTR

P020056	NATRELLE Silicon-Filled Breast Implants	Allergan
P040046	NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants	Allergan
P030053	MemoryGel Silicone Gel-Filled Breast Implants	MENTOR CORP.
P060028	Mentor MemoryShape Breast Implants	MENTOR WORLDWIDE LLC
P070004	Sientra OPUS Silicone Gel Breast Implants	SIENTRA, INC

Global Unique Device Identification Database

• 00812790025916: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025909: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025893: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025886: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025879: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025862: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025855: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025848: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025831: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025824: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025817: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025800: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025756: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025749: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
• 00812790025732: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Maude Adverse Events

MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
UNKNOWN GEL IMPLANTS TEXTURED	MENTOR TEXAS	2020-03-31
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 115 SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
MENTOR MEMORYGEL BREAST IMPLANT	MENTOR TEXAS	2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 40 SILICONE GEL FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31