PMA P850010S117

Device: Helistat® Absorbable Collagen Hemostatic Agent
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S117
Product code: LMF
Decision date: 2026-05-27
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
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: Helistat® Absorbable Collagen Hemostatic Agent
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S117
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
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