FLOSEAL HEMOSTATIC MATRIX
FDA premarket approval P990009/S035 · decided 2013-09-19
Approval details
- PMA number
- P990009
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLOSEAL HEMOSTATIC MATRIX
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Baxter Healthcare Corp
- Date received
- 2013-03-25
- Decision date
- 2013-09-19
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- APROVAL TO CHANGE THE WARNING STATEMENT `THE SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 2 YEARS OF AGE AND PREGNANT WOMEN¿.
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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 |