PMA P960042S031
- Device
- SPECTRANETICS LASER SHEATH DEVICE
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S031
- Product code
- MFA
- Decision date
- 2012-04-20
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE MAXIMUM REPETITION RATE FROM 40 HZ TO 80 HZ OF THE SPECTRANETICS LASER SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLIDELIGHT LASER SHEATH.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH DEVICE
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S031
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2012-04-20
- Decision code
- APPR
- Date received
- 2011-09-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE MAXIMUM REPETITION RATE FROM 40 HZ TO 80 HZ OF THE SPECTRANETICS LASER SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLIDELIGHT LASER SHEATH.