PMA P980022S012

Device: GUARDIAN RT
Applicant: Medtronic Minimed
PMA number: P980022
Supplement: S012
Product code: MDS
Decision date: 2005-08-24
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE SENSOR TO INCLUDE THE USE OF HUMAN SERUM ALBUMIN IN PLACE OF BOVINE SERUM ALBUMIN AS A STABILIZER AND A CHANGE TO THE MANUFACTURING PROCESS REMOVING THE OUTER HYDROPHILIC MEMBRANE.

Current openFDA PMA Record#

Device: GUARDIAN RT
Applicant: Medtronic Minimed
PMA number: P980022
Supplement: S012
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2005-08-24
Decision code: APPR
Date received: 2005-02-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE SENSOR TO INCLUDE THE USE OF HUMAN SERUM ALBUMIN IN PLACE OF BOVINE SERUM ALBUMIN AS A STABILIZER AND A CHANGE TO THE MANUFACTURING PROCESS REMOVING THE OUTER HYDROPHILIC MEMBRANE.