PMA P100023S051
- Device
- ION PACLITAXEL-ELUTING CORONARY SYSTEM (MONORAIL AND OVER THE WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S051
- Product code
- NIQ
- Decision date
- 2012-08-22
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- PRE-STERILIZATION EQUIPMENT CHANGE TO THE ETHYLENE OXIDE STERILIZATION PROCESS FOR THE DEVICE.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY SYSTEM (MONORAIL AND OVER THE WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S051
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-08-22
- Decision code
- OK30
- Date received
- 2012-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- PRE-STERILIZATION EQUIPMENT CHANGE TO THE ETHYLENE OXIDE STERILIZATION PROCESS FOR THE DEVICE.