0.7 MM EXTREME CATHETER
FDA premarket approval P910001/S021 · decided 2003-02-04
Approval details
- PMA number
- P910001
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 0.7 MM EXTREME CATHETER
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 2002-09-05
- Decision date
- 2003-02-04
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR THE 0.7 MM SIZE OF THE EXTREME OTW X80 PERCUTANEOUS EXCIMER LASER CORONARY ANGIOPLASTY CATHETER.
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