PMA P960042S049
- Device
- SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S049
- Product code
- MFA
- Decision date
- 2014-10-09
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S049
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2014-10-09
- Decision code
- APPR
- Date received
- 2014-07-14
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.