CRYOMAX(TM)
FDA premarket approval P820002 · decided 1983-01-31
Approval details
- PMA number
- P820002
- Trade name
- CRYOMAX(TM)
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Strato Medical Corp.
- Date received
- 1982-01-05
- Decision date
- 1983-01-31
- Days to decision
- 391 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Beverly, MA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS (K945956) | Strato Medical Corp. | 1995-06-06 |
| STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS (K946250) | Strato Medical Corp. | 1995-05-02 |
| STRATO MEDICAL LIFEPORT LPS 7515 (K942848) | Strato Medical Corp. | 1995-02-01 |
| STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM (K934518) | Strato Medical Corp. | 1995-01-27 |
| STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT (K932509) | Strato Medical Corp. | 1994-01-07 |
| STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM (K933884) | Strato Medical Corp. | 1993-12-30 |
| STRATO MEDICAL SINGLE LUMEN VALVED CATHETER (K924851) | Strato Medical Corp. | 1993-12-13 |
| STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH (K924677) | Strato Medical Corp. | 1993-07-30 |