PMA P960042S037

Device
SLS SPECTRANETICS LASER SHEATHS
Applicant
Spectranetics (Philips)
PMA number
P960042
Supplement
S037
Product code
MFA
Decision date
2012-05-16
Classification
Device, Removal, Pacemaker Electrode, Percutaneous
Generic name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement
APPROVAL FOR QUALIFYING THE USE OF LOCTITE 7701 AS A SUITABLE REPLACEMENT FOR THE DISCONTINUED LOCTITE 793.

Current openFDA PMA Record#

Device
SLS SPECTRANETICS LASER SHEATHS
Applicant
Spectranetics (Philips)
PMA number
P960042
Supplement
S037
Product code
MFA
Generic name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date
2012-05-16
Decision code
APPR
Date received
2012-04-10
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR QUALIFYING THE USE OF LOCTITE 7701 AS A SUITABLE REPLACEMENT FOR THE DISCONTINUED LOCTITE 793.