PMA P910001S027

Device: SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S027
Product code: LPC
Decision date: 2009-03-25
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
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: SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S027
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
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.