Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath
FDA premarket approval P960042/S057 · decided 2017-05-10
Approval details
- PMA number
- P960042
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2017-04-10
- Decision date
- 2017-05-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- 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.
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