FWM

Product Code: FWM

Products Classified as FWM

5546

Prosthesis, Breast, Inflatable, Internal, Saline

Silicone Inflatable Breast Prosthesis.

Total Product Life Cycle (TPLC) Devices

5546

Prosthesis, Breast, Inflatable, Internal, Saline

Silicone Inflatable Breast Prosthesis.

FDA Consensus Standards

• Prosthesis, Breast, Inflatable, Internal, Saline [37532]: 21 CFR §878.3530 🔎
• Prosthesis, Breast, Inflatable, Internal, Saline [33203]: 21 CFR §878.3530 🔎

Pre-market Approvals for FWM

P120011	IDEAL IMPLANT Structured Breast Implant	IDEALIMPLANT
P990075	Mentor Saline-Filled and SPECTRUM Breast Implants	MENTOR WORLDWIDE LLC
P990074	NATRELLE Saline-Filled Breast Implants	Allergan

Global Unique Device Identification Database

• 00081317009054: Prosthesis, breast, inflatable, internal, saline
• 00081317009047: Prosthesis, breast, inflatable, internal, saline
• 00081317009030: Prosthesis, breast, inflatable, internal, saline
• 00081317004561: Prosthesis, breast, inflatable, internal, saline
• 00081317004059: Prosthesis, breast, inflatable, internal, saline
• 00081317002178: Prosthesis, breast, inflatable, internal, saline
• 00081317002161: Prosthesis, breast, inflatable, internal, saline
• 00081317002154: Prosthesis, breast, inflatable, internal, saline
• 00081317002147: Prosthesis, breast, inflatable, internal, saline
• 00081317002130: Prosthesis, breast, inflatable, internal, saline
• 00081317002123: Prosthesis, breast, inflatable, internal, saline
• 00081317002116: Prosthesis, breast, inflatable, internal, saline
• 00081317002109: Prosthesis, breast, inflatable, internal, saline
• 00081317002093: Prosthesis, breast, inflatable, internal, saline
• 00081317002086: Prosthesis, breast, inflatable, internal, saline

Maude Adverse Events

MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS TEXTURED	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE	MENTOR TEXAS	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS SMOOTH	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
UNK MAMMARY IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
UNK SALINE IMPLANT		2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
UNK SALINE IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
UNKNOWN SALINE IMPLANTS SMOOTH	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND HIGH PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND HIGH PROFILE	MENTOR TEXAS	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
UNK MAMMARY IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
UNK MAMMARY IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
MENTOR SILTEX ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SILTEX ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND HIGH PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND HIGH PROFILE	MENTOR TEXAS	2020-03-31
UNK MAMMARY IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
UNKNOWN TEXTURED SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
UNKNOWN TEXTURED SALINE IMPLANTS	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE	MENTOR TEXAS	2020-03-31
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE	MENTOR TEXAS	2020-03-31
UNK MAMMARY IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31
STYLE 68 SALINE FILLED BREAST IMPLANT	ALLERGAN (COSTA RICA)	2020-03-31