MEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM
FDA premarket approval P970035/S042 · decided 2002-10-02
Approval details
- PMA number
- P970035
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2002-08-23
- Decision date
- 2002-10-02
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR THE MEDTRONIC AVE S660 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM.
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