PMA P840062S097

Device: CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S097
Product code: LPG
Decision date: 2026-05-27
Classification: Dental
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement: an extension of Dirty Hold Time (DHT) for equipment used in cutting collagen during the manufacture of absorbable collagen products, and the installation of a new Clean Compressed Air Point of Use utility in the alternative ISO 8 Cleanroom

Current openFDA PMA Record#

Device: CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S097
Product code: LPG
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date: 2026-05-27
Decision code: OK30
Date received: 2026-04-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an extension of Dirty Hold Time (DHT) for equipment used in cutting collagen during the manufacture of absorbable collagen products, and the installation of a new Clean Compressed Air Point of Use utility in the alternative ISO 8 Cleanroom