SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
FDA premarket approval P810046/S042 · decided 1988-02-29
Approval details
- PMA number
- P810046
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1987-12-22
- Decision date
- 1988-02-29
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.