SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
FDA premarket approval P990075/S001 · decided 2001-02-27
Approval details
- PMA number
- P990075
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2000-06-08
- Decision date
- 2001-02-27
- Days to decision
- 264 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR THE MENTOR SALINE AND SPECTRUM MAMMARY PROSTHESES RETRIEVAL PROTOCOL.
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