CORONARY DILATATION CATHETER
FDA premarket approval P810046/S208 · decided 2001-06-05
Approval details
- PMA number
- P810046
- Supplement
- S208
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2001-05-10
- Decision date
- 2001-06-05
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR MODIFICATIONS OF WHITE FOIL MARKERS IN THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), AND ACS ESPRIT PTCA CATHETERS.
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