PMA P960042S057
- Device
- Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S057
- Product code
- MFA
- Decision date
- 2017-05-10
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- Updates to the tubing extrusion process, including the following: an update to the process parameters, a new supplier of some tubing components, the addition of new tooling/equipment, and an update to the inspection test method.
Current openFDA PMA Record#
- Device
- Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S057
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2017-05-10
- Decision code
- OK30
- Date received
- 2017-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the tubing extrusion process, including the following: an update to the process parameters, a new supplier of some tubing components, the addition of new tooling/equipment, and an update to the inspection test method.