PMA P100023S075
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S075
- Product code
- NIQ
- Decision date
- 2013-07-28
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- MODIFICATIONS TO REDUCE THE INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.
Current openFDA PMA Record
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S075
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-07-28
- Decision code
- OK30
- Date received
- 2013-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATIONS TO REDUCE THE INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.