SIMPSON CORONARY ATHEROCATH(TM)
FDA premarket approval P890043/S027 · decided 1995-08-17
Approval details
- PMA number
- P890043
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SIMPSON CORONARY ATHEROCATH(TM)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 1994-05-12
- Decision date
- 1995-08-17
- Days to decision
- 462 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR REVISED PRODUCT LABELING FOR THE SCA-EX AND ATHEROCATH-GTO MODELS OF THE SIMPSON CORONARY ATHEROCATH
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