Ideal Implant Saline-filled Breast Implant
FDA premarket approval P120011/S010 · decided 2017-11-17
Approval details
- PMA number
- P120011
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ideal Implant Saline-filled Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2017-10-23
- Decision date
- 2017-11-17
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
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