PMA P810006S093

Device: Collastat™ Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S093
Product code: LMF
Decision date: 2021-02-04
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Add an additional sealer and sealing tool for the packaging of the Helistat and OraFoam ½ inch x 1.0 inch product configuration.

Current openFDA PMA Record#

Device: Collastat™ Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S093
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2021-02-04
Decision code: OK30
Date received: 2021-01-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an additional sealer and sealing tool for the packaging of the Helistat and OraFoam ½ inch x 1.0 inch product configuration.