PALMZ BALLOON EXPANDABLE STENTS
FDA premarket approval P890017/S008 · decided 2000-07-11
Approval details
- PMA number
- P890017
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PALMZ BALLOON EXPANDABLE STENTS
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 2000-03-23
- Decision date
- 2000-07-11
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL TO MODIFY THE DEVICE LABELING TO SPECIFY THE CORDIS MAXI DS BALLOON CATHETER AS THE RECOMMENDED DELIVERY SYSTEM FOR THE P308 PALMAZ(TM) BALLOON EXPANDABLE STENT.
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