PMA P900033S102

Device: INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S102
Product code: MGR
Decision date: 2022-07-01
Generic name: Dressing, wound and burn, interactive
Approval order statement: Change is to the lyophilization software to ensure it returns data values in daylight savings time, to ensure that data points are properly reported with the actual time the value occurred.

Current openFDA PMA Record#

Device: INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S102
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2022-07-01
Decision code: OK30
Date received: 2022-06-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change is to the lyophilization software to ensure it returns data values in daylight savings time, to ensure that data points are properly reported with the actual time the value occurred.