PALMAZ Balloon Expandable Stent
FDA premarket approval P890017/S020 · decided 2019-08-21
Approval details
- PMA number
- P890017
- Supplement
- S020
- Supplement type
- 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
- 2019-07-23
- Decision date
- 2019-08-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Transfer Receiving Inspection and Final Release documentation review activities between internal sites.
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