NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM
FDA premarket approval P980001/S013 · decided 1999-11-04
Approval details
- PMA number
- P980001
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- Date received
- 1999-10-06
- Decision date
- 1999-11-04
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- 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.
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