- Device
- SPECTRANETICS LASER SHEATH (SLS)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S012
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2009-11-05
- Decision code
- APPR
- Date received
- 2009-04-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, LLC, SALT LAKE CITY, UTAH FOR STERILIZATION PACKAGING.