SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS
FDA premarket approval P890043/S033 · decided 1999-09-30
Approval details
- PMA number
- P890043
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 1998-12-23
- Decision date
- 1999-09-30
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- 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.
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