PMA P100023S077
- Device
- ION PACLITAEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S077
- Product code
- NIQ
- Decision date
- 2013-09-27
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- P050019/S0179/27/13 CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311 USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
Current openFDA PMA Record
- Device
- ION PACLITAEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S077
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-09-27
- Decision code
- OK30
- Date received
- 2013-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- P050019/S0179/27/13 CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311 USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.