PMA P960042S036

Device
SLS SPECTRANETICS LASER SHEATHS
Applicant
Spectranetics (Philips)
PMA number
P960042
Supplement
S036
Product code
MFA
Decision date
2012-05-24
Classification
Device, Removal, Pacemaker Electrode, Percutaneous
Generic name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement
APPROVAL FOR A MODIFICATION TO THE FISH TAPE ACCESSORY OF THE DEVICE.

Current openFDA PMA Record#

Device
SLS SPECTRANETICS LASER SHEATHS
Applicant
Spectranetics (Philips)
PMA number
P960042
Supplement
S036
Product code
MFA
Generic name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date
2012-05-24
Decision code
APPR
Date received
2012-04-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MODIFICATION TO THE FISH TAPE ACCESSORY OF THE DEVICE.