PMA P850010S102

Device: Helistat® and Helitene® Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S102
Product code: LMF
Decision date: 2022-05-20
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of the current two (2) modules of the water purification (RODEI) system with four (4) like-in-kind modules from the same manufacturer to increase purified water capacity at the Integra NeuroSciences manufacturing facility located at Road 402 North, Km 1.2 Añasco, PR 00610.

Current openFDA PMA Record#

Device: Helistat® and Helitene® Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S102
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2022-05-20
Decision code: OK30
Date received: 2022-04-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the current two (2) modules of the water purification (RODEI) system with four (4) like-in-kind modules from the same manufacturer to increase purified water capacity at the Integra NeuroSciences manufacturing facility located at Road 402 North, Km 1.2 Añasco, PR 00610.