PALMAZ BALLOON EXPANDABLE STENT
FDA premarket approval P890017/S009 · decided 2000-07-11
Approval details
- PMA number
- P890017
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PALMAZ BALLOON EXPANDABLE STENT
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 2000-05-26
- Decision date
- 2000-07-11
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A REVISED INSTRUCTIONS FOR USE (IFU) FOR THE CORDIS PALMAZ(TM) BALLOON EXPANDABLE STENT.
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