PMA P900033S058

Device: INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S058
Product code: MGR
Decision date: 2017-01-26
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval for a new device size (2.5cm x 2.5 cm) for both the meshed and non-meshed forms of Integra Omnigraft Dermal Regeneration Matrix.

Current openFDA PMA Record#

Device: INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S058
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2017-01-26
Decision code: APPR
Date received: 2016-11-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new device size (2.5cm x 2.5 cm) for both the meshed and non-meshed forms of Integra Omnigraft Dermal Regeneration Matrix.