PMA P840062S095

Device: CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S095
Product code: LPG
Decision date: 2025-02-18
Classification: Dental
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement: for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples

Current openFDA PMA Record#

Device: CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S095
Product code: LPG
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date: 2025-02-18
Decision code: OK30
Date received: 2025-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples