SPECTRANETICS LASER SHEATHS (SLS)
FDA premarket approval P960042/S048 · decided 2014-04-17
Approval details
- PMA number
- P960042
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANETICS LASER SHEATHS (SLS)
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2014-03-19
- Decision date
- 2014-04-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- CHANGE TO ESTABLISH THE OPERATING RANGE WITHIN WHICH THE FIBER WINDER CAN SPOOL FIBER FOR THE SLS AND ELCA PRODUCT LINES.
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