FLOSEAL NT HEMOSTATIC MATRIX
FDA premarket approval P990009/S014 · decided 2003-07-10
Approval details
- PMA number
- P990009
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLOSEAL NT HEMOSTATIC MATRIX
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Baxter Healthcare Corp
- Date received
- 2003-04-29
- Decision date
- 2003-07-10
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- APPROVAL FOR AN ALTERNATE TRADE NAME FOR THE APPROVED KIT CONFIGURATION THAT DOES NOT CONTAIN A THROMBIN COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL NT HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |