PMA P100023S081
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S081
- Product code
- NIQ
- Decision date
- 2013-12-20
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S081
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-12-20
- Decision code
- OK30
- Date received
- 2013-11-25
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.