PMA P980001S025
- Device
- NIR PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S025
- Decision date
- 2000-10-12
- Approval order statement
- THE 30-DAY NOTICE PROPOSED A CHANGE IN AN IN-PROCESS INSPECTION STEP TO REMOVE THE STENT IMPRINT AS A REJECTION CRITERION FOR THE ELASTOMERIC RETAINING SLEEVE COMPONENT ACCEPTANCE
Current openFDA PMA Record
- Device
- NIR PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S025
- Decision date
- 2000-10-12
- Decision code
- OK30
- Date received
- 2000-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THE 30-DAY NOTICE PROPOSED A CHANGE IN AN IN-PROCESS INSPECTION STEP TO REMOVE THE STENT IMPRINT AS A REJECTION CRITERION FOR THE ELASTOMERIC RETAINING SLEEVE COMPONENT ACCEPTANCE