PALMAZ BALLOON-EXPANDABLE STENT/ILIAC ARTERIES
FDA premarket approval P890017/S004 · decided 1996-05-20
Approval details
- PMA number
- P890017
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PALMAZ BALLOON-EXPANDABLE STENT/ILIAC ARTERIES
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 1994-02-22
- Decision date
- 1996-05-20
- Days to decision
- 818 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- ALTERNATE MANUFACTURING FACILITY FOR FINISHING, PACKAGING, AND DISTRIBUTION OF THE DEVICE
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