FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)
FDA premarket approval P990009/S009 · decided 2001-08-10
Approval details
- PMA number
- P990009
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Baxter Healthcare Corp
- Date received
- 2001-06-26
- Decision date
- 2001-08-10
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM, THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE INDICATIONS STATEMENT AND THE ADDITION OF THE NASAL/SINUS INSTRUCTIONS AND INORMATION TO THE LABELING OF THE "DRY" FORM OF THE FUSION MATRIX PRODUCT.
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 |
|---|---|---|
| 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 |