MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES
FDA premarket approval P990075/S028 · decided 2014-11-19
Approval details
- PMA number
- P990075
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2014-10-22
- Decision date
- 2014-11-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- CHANGE TO ADD AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA) USED IN THE PRODUCTION OF SPECTRUM AND SALINE-FILLED BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
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