SALINE-FILLED & SPECTRUM BREAST IMPLANTS
FDA premarket approval P990075/S022 · decided 2013-10-08
Approval details
- PMA number
- P990075
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SALINE-FILLED & SPECTRUM BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2011-02-11
- Decision date
- 2013-10-08
- Days to decision
- 970 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR UPDATED LABELING INCORPORATING INFORMATION ON ANAPLASTIC LARGE CELL LYMPHOMA (ALCL).
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