NIR CORONARY STENT WITH DELIVERY SYSTEM
FDA premarket approval P980001/S035 · decided 2001-08-16
Approval details
- PMA number
- P980001
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NIR CORONARY STENT WITH DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- Date received
- 2001-07-12
- Decision date
- 2001-08-16
- Days to decision
- 35 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
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