MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM
FDA premarket approval P870043/S013 · decided 1991-08-20
Approval details
- PMA number
- P870043
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Trimedyne, Inc.
- Date received
- 1990-12-06
- Decision date
- 1991-08-20
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Forest, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VAPORMAX II (K053457) | Trimedyne, Inc. | 2005-12-21 |
| VAPORMAX (K050412) | Trimedyne, Inc. | 2005-03-14 |
| OMNIPULSE MINI, MODEL 2120 (K043012) | Trimedyne, Inc. | 2004-11-17 |
| TRIMEDYNE HOLMIUM LASER SYSTEMS (K041660) | Trimedyne, Inc. | 2004-09-08 |
| TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (K022655) | Trimedyne, Inc. | 2002-11-07 |
| RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (K013974) | Trimedyne, Inc. | 2002-09-23 |
| OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A (K002308) | Trimedyne, Inc. | 2000-12-20 |
| OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A (K001676) | Trimedyne, Inc. | 2000-11-02 |