PMA P960042S010

Device: CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S010
Product code: MFA
Decision date: 2009-03-25
Classification: Device, Removal, Pacemaker Electrode, Percutaneous
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement: APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION.

Current openFDA PMA Record#

Device: CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S010
Product code: MFA
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date: 2009-03-25
Decision code: APPR
Date received: 2008-10-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION.