Ideal Implant Saline-Filled Breast Implant
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Puregraft Serene Breast Implant FDA PMA
- Generic Name
- Prosthesis, breast, inflatable, internal, saline FDA PMA
Identifiers
- PMA Number
- P120011 FDA PMA
- FDA Product Code
- FWM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 878.3530 FDA PMA
- Regulation Number
- 878.3530 FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Ideal Implant Saline-Filled Breast Implant is a saline-filled, inflatable internal breast prosthesis designed for primary and revision augmentation procedures. Classified as a Prosthesis, Breast, Inflatable, Internal, Saline, it is intended for women aged 18 and older seeking breast size augmentation or correction of prior augmentation results.
This device is supplied sterile and intended for single-use in controlled surgical settings. It is regulated under FDA PMA (Premarket Approval) and falls under Device Class III, with product codes listed under FWM. Multiple model references are available, and MRI safety is implied by saline fill, though specific compatibility should be confirmed with facility protocols. Storage and handling must adhere to sterile surgical standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120011 | Class III | Active |
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Manufacturer
- Manufacturer
- Bimini Health Tech
Sources (1)
- FDA PMA P120011 24 fields · synced Sep 18, 2026