PMA P810006S075

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S075
Product code: LMF
Decision date: 2017-03-01
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Acknowledge Integras revisions to Integras LifeSciences Standard Operating Procedure (SOP) QTM-10-007 - Design Output Variable, and Manufacturing Control Quality Assurance Levels, to align with the recently updated ISO 14971:2012 Medical devices - Application of risk management to medical devices.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S075
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2017-03-01
Decision code: OK30
Date received: 2017-01-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Acknowledge Integras revisions to Integras LifeSciences Standard Operating Procedure (SOP) QTM-10-007 - Design Output Variable, and Manufacturing Control Quality Assurance Levels, to align with the recently updated ISO 14971:2012 Medical devices - Application of risk management to medical devices.