LASTAC SYSTEM
FDA premarket approval P870071/S006 · decided 1991-06-25
Approval details
- PMA number
- P870071
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LASTAC SYSTEM
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- G V Medical, Inc.
- Date received
- 1989-08-22
- Decision date
- 1991-06-25
- Days to decision
- 672 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE (K851080) | G V Medical, Inc. | 1985-06-20 |