PMA P840062S091

Device: CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S091
Product code: LPG
Decision date: 2024-02-21
Classification: Dental
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement: qualification of a new external Process Challenge Device, and an update to the quantity of internal and external Process Challenge Devices used in Performance Qualification and routine monitoring of the ethylene oxide sterilization cycle

Current openFDA PMA Record#

Device: CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S091
Product code: LPG
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date: 2024-02-21
Decision code: OK30
Date received: 2024-01-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of a new external Process Challenge Device, and an update to the quantity of internal and external Process Challenge Devices used in Performance Qualification and routine monitoring of the ethylene oxide sterilization cycle