FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
FDA premarket approval P990028/S002 · decided 2001-07-16
Approval details
- PMA number
- P990028
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
- Generic name
- Mesh, surgical, polymeric
- Applicant
- Genzyme Corp.
- Date received
- 2001-01-09
- Decision date
- 2001-07-16
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- FTL
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT CHESAPEAKE BIOLOGICAL LABORATORIES, INC., BALTIMORE, MD. THE FACILITY WILL PERFORM THE ASEPTIC FORMULATION AND FILLING OF PRIMER VIAL 2 OF FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OSOM INFLUENZA A&B TEST (K061508) | Genzyme Corp. | 2006-06-12 |
| GENZYME OSOM INFLUENZA A & B TEST (K051244) | Genzyme Corp. | 2006-02-21 |
| N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (K040241) | Genzyme Corp. | 2004-06-25 |
| SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (K040868) | Genzyme Corp. | 2004-06-04 |
| GENZYME OSOM TRICHOMONAS RAPID TEST (K033864) | Genzyme Corp. | 2004-04-02 |
| GENZYME CONTRAST II HCG URINE/SERUM TEST (K023544) | Genzyme Corp. | 2003-01-16 |
| ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR (K021316) | Genzyme Corp. | 2002-07-25 |
| COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (K021019) | Genzyme Corp. | 2002-06-18 |