PALMAZ BALLOON EXPANDABLE STENT
FDA premarket approval P890017/S018 · decided 2016-09-28
Approval details
- PMA number
- P890017
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PALMAZ BALLOON EXPANDABLE STENT
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 2016-03-01
- Decision date
- 2016-09-28
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for a change to the packaging materials for the PALMAZ Balloon-Expandable Stent.
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