PMA P100023S090
- Device
- ION (TAXUS ELEMENT) CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S090
- Product code
- NIQ
- Decision date
- 2014-03-25
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.
Current openFDA PMA Record
- Device
- ION (TAXUS ELEMENT) CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S090
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-03-25
- Decision code
- OK30
- Date received
- 2014-02-25
- Supplement type
- 30-Day Notice
- Approval order statement
- ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.