PALMAZ BALLOON-EXPANDABLE STENT
FDA premarket approval P890017/S010 · decided 2002-07-10
Approval details
- PMA number
- P890017
- Supplement
- S010
- Supplement type
- Panel 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
- 2001-12-06
- Decision date
- 2002-07-10
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE CORDIS PALMAZ BALLOON EXPANDABLE STENT (MODELS P104R, P154R, P204R). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUBOPTIMAL PERCUTANEOUS RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC LESION (<=22 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE AORTORENAL ARTERY BORDER AND WITH A REFERENCE VESSEL DIAMETER OF >= 4 MM AND <= 8 MM. SUBOPTIMAL PTRA RESULTS ARE DEFINED BY ONE OR MORE OF THE FOLLOWING UNFAVORABLE RESULTS: >=
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