PMA P100023S005
- Device
- ION PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S005
- Product code
- NIQ
- Decision date
- 2012-03-23
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
Current openFDA PMA Record
- Device
- ION PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S005
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-03-23
- Decision code
- APPR
- Date received
- 2011-06-21
- 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 ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.