PMA P100023S002
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S002
- Product code
- NIQ
- Decision date
- 2011-10-25
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- APPROVAL FOR CHANGES TO IN-PROCESS MONITORING (IPM) REQUIREMENTS.
Current openFDA PMA Record
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S002
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-10-25
- Decision code
- APPR
- Date received
- 2011-05-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO IN-PROCESS MONITORING (IPM) REQUIREMENTS.