SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS.
FDA premarket approval P990075/S009 · decided 2002-09-03
Approval details
- PMA number
- P990075
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2002-07-01
- Decision date
- 2002-09-03
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR REVISED LABELING THAT REFLECTS 5-YEAR POST-APPROVAL STUDY DATA.
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