PALMAZ BALLON-EXPANABLE STENT
FDA premarket approval P890017/S006 · decided 1999-02-05
Approval details
- PMA number
- P890017
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PALMAZ BALLON-EXPANABLE STENT
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 1998-12-31
- Decision date
- 1999-02-05
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for a manufacturing site located at Cordis Corporation, 14201 N.W. 60th Ave., Miami Lakes, FL 33014.
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