PMA P980001
- Device
- NIR PREMOUNTED STENT DELIVERY SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S027
- Product code
- MAF
- Decision date
- 2003-07-25
- Generic name
- STENT, CORONARY
- Approval order statement
- CHANGE TO THE MANUFACTURING COATING PROCESS FOR ALL CURRENTLY MARKETED PTCA CATHETERS AND CORONARY STENT (BALLOON EXPANDABLE) DELIVERY SYSTEMS.
Current openFDA PMA Record
- Device
- NIR PREMOUNTED STENT DELIVERY SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S043
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2003-07-25
- Decision code
- OK30
- Date received
- 2003-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURING COATING PROCESS FOR ALL CURRENTLY MARKETED PTCA CATHETERS AND CORONARY STENT (BALLOON EXPANDABLE) DELIVERY SYSTEMS.