PMA P900033S108

Device: Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S108
Product code: MGR
Decision date: 2023-08-21
Classification: General, Plastic Surgery
Generic name: Dressing, wound and burn, interactive
Approval order statement: Qualification of modifications to the Cleans team (CS) System at the Collagen Manufacturing Center at 109 Morgan Lane in Plainsboro, NJ.

Current openFDA PMA Record#

Device: Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S108
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2023-08-21
Decision code: OK30
Date received: 2023-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of modifications to the Cleans team (CS) System at the Collagen Manufacturing Center at 109 Morgan Lane in Plainsboro, NJ.