PMA P100023S001
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S001
- Product code
- NIQ
- Decision date
- 2011-06-07
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- CHANGES TO YOUR CUT-TO-LENGTH PROCESS DURING CATHETER ASSEMBLY.
Current openFDA PMA Record
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S001
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-06-07
- Decision code
- OK30
- Date received
- 2011-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO YOUR CUT-TO-LENGTH PROCESS DURING CATHETER ASSEMBLY.