PMA P900033S082

Device: INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Interga Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S082
Product code: MGR
Decision date: 2019-08-08
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Reduce the sample size for Bacterial Endotoxin Testing for Integra products in conformance with ANSI/AAMI ST-072 standard.

Current openFDA PMA Record#

Device: INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Interga Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S082
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2019-08-08
Decision code: OK30
Date received: 2019-07-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the sample size for Bacterial Endotoxin Testing for Integra products in conformance with ANSI/AAMI ST-072 standard.