COSTASIS/DYNASTAT SURGICAL HEMOSTATS
FDA premarket approval P990030/S003 · decided 2002-03-14
Approval details
- PMA number
- P990030
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSTASIS/DYNASTAT SURGICAL HEMOSTATS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2001-12-27
- Decision date
- 2002-03-14
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL OF THE UROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COSTASIS/DYNASTAT SURGICAL HEMOSTAT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO THE HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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