PMA P810006S100

Device: Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S100
Product code: LMF
Decision date: 2022-07-06
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.

Current openFDA PMA Record#

Device: Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S100
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2022-07-06
Decision code: OK30
Date received: 2022-06-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.