ACS RX COMET CORONARY DILATATION CATHETER
FDA premarket approval P810046/S180 · decided 1997-08-12
Approval details
- PMA number
- P810046
- Supplement
- S180
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS RX COMET CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-07-01
- Decision date
- 1997-08-12
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE INSTRUCTIONS FOR USE.
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