PMA P900033S083

Device: Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S083
Product code: MGR
Decision date: 2019-08-28
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Change to the Water for Injection Pretreatment System for INTEGRA Dermal Regeneration Template and INTEGRA Meshed Dermal Regeneration Template.

Current openFDA PMA Record#

Device: Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S083
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2019-08-28
Decision code: OK30
Date received: 2019-07-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the Water for Injection Pretreatment System for INTEGRA Dermal Regeneration Template and INTEGRA Meshed Dermal Regeneration Template.