PMA P960042S014
- Device
- SPECTRANETICS LASER SHEATH (SLS) CATHETERS
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S014
- Product code
- MFA
- Decision date
- 2009-07-28
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR A CHANGE OF MATERIAL USED TO MAKE THE PROXIMAL COUPLER OF THE CATHETER. THE MATERIAL WILL BE CHANGED FROM DOW MAGNUM 9555 TO SABIC CYCOLAC MG47MD.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH (SLS) CATHETERS
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S014
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2009-07-28
- Decision code
- APPR
- Date received
- 2009-06-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE OF MATERIAL USED TO MAKE THE PROXIMAL COUPLER OF THE CATHETER. THE MATERIAL WILL BE CHANGED FROM DOW MAGNUM 9555 TO SABIC CYCOLAC MG47MD.