VITAGEL RT3 SUTGICAL HEMOSTAT
FDA premarket approval P050044/S033 · decided 2017-03-02
Approval details
- PMA number
- P050044
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITAGEL RT3 SUTGICAL HEMOSTAT
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Stryker Corp.
- Date received
- 2017-01-31
- Decision date
- 2017-03-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- New tray tooling fixture, new sealing parameters and increased outer tray dimensions.
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| 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 |