PMA P980001S013
- Device
- NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S013
- Decision date
- 1999-11-04
- Approval order statement
- The 30-Day Notice requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the NIR(TM) PRIMO(TM) Premounted Stent Delivery System.
Current openFDA PMA Record
- Device
- NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S013
- Decision date
- 1999-11-04
- Decision code
- OK30
- Date received
- 1999-10-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the NIR(TM) PRIMO(TM) Premounted Stent Delivery System.