PMA P850010S113

Device: Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S113
Product code: LMF
Decision date: 2024-08-29
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: change the seal strength and sterile barrier system integrity testing from visual “Burst” and “Creep” methods to testing per ASTM F88/F88M to comply with ISO 11607

Current openFDA PMA Record#

Device: Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S113
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2024-08-29
Decision code: OK30
Date received: 2024-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change the seal strength and sterile barrier system integrity testing from visual “Burst” and “Creep” methods to testing per ASTM F88/F88M to comply with ISO 11607