NATRELLE Saline-Filled Breast Implants
FDA premarket approval P990074/S037 · decided 2017-08-28
Approval details
- PMA number
- P990074
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NATRELLE Saline-Filled Breast Implants
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2017-03-01
- Decision date
- 2017-08-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10% (applicable to generic versions as well) from the patient and physician labeling, and 2) 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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510(k) clearances by this applicant
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| NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229) | Allergan | 2021-06-02 |
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| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
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