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Focal Seal-L Synthetic Absorbable Sealant

FDA PMA

Class II (US FDA PMA)

PMA P990028

by Genzyme Corp.

Identity

Trade Name
FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT FDA PMA
Generic Name
Sealant, polymerizing FDA PMA

Identifiers

PMA Number
P990028 FDA PMA
FDA Product Code
NBE FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APWD FDA PMA

The Focal Seal-L Synthetic Absorbable Sealant is a polymerizing sealant used to create a barrier between tissue surfaces. It is designed to be absorbable and synthetic in composition.

This device is supplied as a single-use product and is regulated under FDA PMA authorization. It is intended for use in general and plastic surgery applications, with specific model numbers and sizes as specified by the manufacturer.

Frequently asked questions

What is the Focal Seal-L Synthetic Absorbable Sealant used for?

The Focal Seal-L Synthetic Absorbable Sealant is a polymerizing sealant used to create a barrier between tissue surfaces in general and plastic surgery applications.

Is the Focal Seal-L Synthetic Absorbable Sealant single-use or reusable?

The Focal Seal-L Synthetic Absorbable Sealant is supplied as a single-use product and should not be reused for patient safety and effectiveness.

What is the composition of the Focal Seal-L Synthetic Absorbable Sealant?

The Focal Seal-L Synthetic Absorbable Sealant is synthetic in composition and is designed to be absorbable after application.

How is the Focal Seal-L Synthetic Absorbable Sealant regulated?

The Focal Seal-L Synthetic Absorbable Sealant is regulated under FDA PMA authorization, which indicates it has undergone pre-market approval for safety and effectiveness.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Genzyme Corp.

Sources (1)

  • FDA PMA P990028 24 fields · synced Sep 18, 2026