PMA P900033S101

Device: Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene
Applicant: Integra Lifesciences Corp.
Product code: MGR
Decision date: 2022-07-06
Generic name: Dressing, wound and burn, interactive
Approval order statement: Replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.

Current openFDA PMA Record#

Device: Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S101
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2022-07-06
Decision code: OK30
Date received: 2022-06-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.