SCA-EX 7F GRAFT DEVICE
FDA premarket approval P890043/S022 · decided 1994-04-13
Approval details
- PMA number
- P890043
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCA-EX 7F GRAFT DEVICE
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 1993-07-06
- Decision date
- 1994-04-13
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
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