PMA P890043S033
- Device
- Simpson Coronary Atherocath-sca-ex, Gto And Bantam
- Applicant
- ABBOTT VASCULAR
- PMA number
- P890043
- Supplement
- S033
- Decision date
- 1999-09-30
Current openFDA PMA Record
- Device
- SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S033
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 1999-09-30
- Decision code
- APPR
- Date received
- 1998-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the labeling for the Simpson Coronary AtheroCath(R) SCA-EX(TM), GTO(R), and BANTAM(TM) Atherectomy Catheters to 1) include clinical data from the Balloon versus Optimal Atherectomy Trial (BOAT) and 2) streamline the remainder of the text.