PMA P120011S028

Device: Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant
Applicant: Bimini Health Tech
PMA number: P120011
Supplement: S028
Product code: FWM
Decision date: 2025-02-11
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Approval to update the Instructions for Use and the Patient Information Booklet that were previously reviewed under P120011/S025

Current openFDA PMA Record#

Device: Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant
Applicant: Bimini Health Tech
PMA number: P120011
Supplement: S028
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2025-02-11
Decision code: APPR
Date received: 2024-08-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval to update the Instructions for Use and the Patient Information Booklet that were previously reviewed under P120011/S025