PMA P960042S045

Device
SPECTRANETICS LASER SHEATHS SLS
Applicant
Spectranetics (Philips)
PMA number
P960042
Supplement
S045
Product code
MFA
Decision date
2012-12-26
Classification
Device, Removal, Pacemaker Electrode, Percutaneous
Generic name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement
ADDITION OF A NEW COMPUTER NUMERIC CONTROL (CNC) MACHINING TOOL.

Current openFDA PMA Record#

Device
SPECTRANETICS LASER SHEATHS SLS
Applicant
Spectranetics (Philips)
PMA number
P960042
Supplement
S045
Product code
MFA
Generic name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date
2012-12-26
Decision code
OK30
Date received
2012-11-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW COMPUTER NUMERIC CONTROL (CNC) MACHINING TOOL.