SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
FDA premarket approval P810046/S023 · decided 1986-08-25
Approval details
- PMA number
- P810046
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1986-06-02
- Decision date
- 1986-08-25
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
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