PMA P910001S051

Device: ELCA CORONARY ATHERECTOMY CATHETERS
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S051
Product code: LPC
Decision date: 2012-02-17
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION.

Current openFDA PMA Record#

Device: ELCA CORONARY ATHERECTOMY CATHETERS
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S051
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2012-02-17
Decision code: APPR
Date received: 2011-11-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION.