PMA P100023S102
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S102
- Product code
- NIQ
- Decision date
- 2014-12-08
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S102
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-12-08
- Decision code
- APPR
- Date received
- 2014-06-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.