MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES
FDA premarket approval P990075/S013 · decided 2003-08-14
Approval details
- PMA number
- P990075
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2003-08-01
- Decision date
- 2003-08-14
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- CHANGE IN THE QUALITY CONTROL TEST SPECIFICATION TO REPLACE THE TENSILE STRENGTH SPECIFICATION WITH A BREAK FORCE SPECIFICATION FOR THE SILICONE ELASTOMER FILL TUBE COMPONENT OF THE MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES.
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