VITAGEL SURGICAL HEMOSTAT
FDA premarket approval P050044/S001 · decided 2007-01-25
Approval details
- PMA number
- P050044
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITAGEL SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2006-08-08
- Decision date
- 2007-01-25
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR REVISED CELLPAKER MANUFACTURE BY SPECIAL TEAM MEDICAL SERVICES (YORBA LINDA, CALIFORNIA), TERMINAL STERILIZATION OF THE CELLPAKER BY STERIGENICS US, INC. (SAN DIEGO, CALIFORNIA), AND CHANGE IN CONTRACTOR PERFORMING THE LIMULUS AMEBOCYTE LYSATE ASSAY TO LEXAMED, LTD (TOLEDO, OHIO).
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 |
|---|---|---|
| HipCheck (K230045) | Stryker Corp. | 2023-09-29 |
| Stryker CrossFlow Integrated Arthroscopy Pump (K191259) | Stryker Corp. | 2019-07-12 |
| HipCheck (K182359) | Stryker Corp. | 2018-12-13 |
| Stryker Footed Attachments and Cutting Accessories (K143399) | Stryker Corp. | 2015-05-08 |
| Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K143320) | Stryker Corp. | 2015-04-23 |
| LITe Plate System (K150449) | Stryker Corp. | 2015-03-20 |
| Xia 3 Spinal System (K142381) | Stryker Corp. | 2014-10-21 |
| ICONIX ALL SUTURE ANCHORS (K133671) | Stryker Corp. | 2014-02-28 |