HIGHSAIL CORONARY DILATATION CATHETER
FDA premarket approval P810046/S207 · decided 2001-05-24
Approval details
- PMA number
- P810046
- Supplement
- S207
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIGHSAIL CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2001-05-07
- Decision date
- 2001-05-24
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- MANUFACTURING CHANGE TO MODIFY THE SIDEARM ASSEMBLY AND INSPECTION PROCESS.
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