FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
FDA premarket approval P890043/S038 · decided 2005-01-14
Approval details
- PMA number
- P890043
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Trade name
- FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 2004-12-21
- Decision date
- 2005-01-14
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).
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