PMA P960042S023
- Device
- SPECTRANETICS LASER SHEATH (SLSII)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S023
- Product code
- MFA
- Decision date
- 2011-11-18
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH (SLSII)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S023
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2011-11-18
- Decision code
- APPR
- Date received
- 2010-11-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO.