PMA P890043S027
- Device
- SIMPSON CORONARY ATHEROCATH(TM)
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S027
- Product code
- MCX
- Decision date
- 1995-08-17
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR REVISED PRODUCT LABELING FOR THE SCA-EX AND ATHEROCATH-GTO MODELS OF THE SIMPSON CORONARY ATHEROCATH
Current openFDA PMA Record
- Device
- SIMPSON CORONARY ATHEROCATH(TM)
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S027
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 1995-08-17
- Decision code
- APPR
- Date received
- 1994-05-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED PRODUCT LABELING FOR THE SCA-EX AND ATHEROCATH-GTO MODELS OF THE SIMPSON CORONARY ATHEROCATH