ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS
FDA premarket approval P810046/S213 · decided 2002-10-23
Approval details
- PMA number
- P810046
- Supplement
- S213
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS
- Generic name
- CATHETER, FLOW DIRECTED
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2002-09-27
- Decision date
- 2002-10-23
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- DYG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS.
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