SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
FDA premarket approval P990075/S016 · decided 2005-07-27
Approval details
- PMA number
- P990075
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2005-06-27
- Decision date
- 2005-07-27
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR 1) NEW STYLE 2000 MODERATE PLUS PROFILE, WHICH IS CONSIDERED A MODIFICATION TO THE EXISTING PRODUCT INE, WITH SIZES 175CC-800CC; 2) ADDITIONAL SIZES OF 400CC, 450CC, 500CC, 600CC, 650CC AND 800CC FOR STYLE 1600; AND 3) ADDITIONAL SIZES OF 350CC, 400CC, 700CC, 770CC, AND 800CC FOR STYLE 3000. THERE ARE NO CHANGES TO THE INDICATIONS FOR USE.
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