CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
FDA premarket approval P960042/S010 · decided 2009-03-25
Approval details
- PMA number
- P960042
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2008-10-30
- Decision date
- 2009-03-25
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION.
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