FLOSEAL HEMOSTATIC MATRIX
FDA premarket approval P990009/S044 · decided 2017-02-10
Approval details
- PMA number
- P990009
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLOSEAL HEMOSTATIC MATRIX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Baxter Healthcare Corp
- Date received
- 2016-11-02
- Decision date
- 2017-02-10
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- Approval for modifications to the device design, material, labeling, and packaging, including: replacement of the 10 mL syringe assembly to align with the current 5 mL syringe design, removal of bowel for thrombin, removal of thrombin stickers, removal of malleable tip applicator (10 mL configuration only), removal of luer connector (10 mL configuration only), modification to the needle-free vial access device (VAD), incorporation of thrombin pouch assembly, modification of diluent container, re
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PrisMax System Version 2 (K190910) | Baxter Healthcare Corp | 2019-07-25 |
| PrisMax Control Unit (K163530) | Baxter Healthcare Corp | 2017-05-03 |
| ULTRAFUSE (K130531) | Baxter Healthcare Corp | 2014-04-08 |
| NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS (K132734) | Baxter Healthcare Corp | 2013-10-08 |
| LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245) | Baxter Healthcare Corp | 2013-03-01 |
| INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874) | Baxter Healthcare Corp | 2013-01-10 |
| INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868) | Baxter Healthcare Corp | 2013-01-08 |
| FLOWEASE [SUBCUTANEOUS] INFUSION SET (K121092) | Baxter Healthcare Corp | 2012-06-29 |