PMA P890043S032
- Device
- ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S032
- Product code
- MCX
- Decision date
- 1998-06-08
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for a change in the biological indicator incubation time from 7 to 5 days.
Current openFDA PMA Record
- Device
- ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S032
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 1998-06-08
- Decision code
- APPR
- Date received
- 1997-07-09
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the biological indicator incubation time from 7 to 5 days.