PMA P840062S086

Device: CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S086
Product code: LPG
Decision date: 2022-07-06
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
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: CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S086
Product code: LPG
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
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.