NIR STENT DELIVERY SYSTEMS
FDA premarket approval P980001/S038 · decided 2001-09-26
Approval details
- PMA number
- P980001
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NIR STENT DELIVERY SYSTEMS
- Applicant
- Boston Scientific Corp
- Date received
- 2001-08-30
- Decision date
- 2001-09-26
- Days to decision
- 27 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- ALTERNATIVE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR NIR(R) AND NIROYAL(R) STENT DELIVERY SYSTEMS. THE ALTERNATIVE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.
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