PMA P960042S032

Device: SLS SPECTRANETICS LASER SHEATHS
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S032
Product code: MFA
Decision date: 2012-02-17
Classification: Device, Removal, Pacemaker Electrode, Percutaneous
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
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: SLS SPECTRANETICS LASER SHEATHS
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S032
Product code: MFA
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
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.