PMA P910001S017
- Device
- ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S017
- Product code
- LPC
- Decision date
- 2000-03-17
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- The 135-day supplement requested approval for the addition of ethylene oxide sterilization equipment.
Current openFDA PMA Record#
- Device
- ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S017
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- 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 approval for the addition of ethylene oxide sterilization equipment.