PMA P960042S005
- Device
- SPECTRANETICS LASER SHEATHS (SLS)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S005
- Decision date
- 2000-03-17
- Approval order statement
- The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATHS (SLS)
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S005
- Decision date
- 2000-03-17
- Decision code
- APPR
- Date received
- 1999-09-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.