SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
FDA premarket approval P960042/S053 · decided 2016-04-13
Approval details
- PMA number
- P960042
- Supplement
- S053
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2016-03-14
- Decision date
- 2016-04-13
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.
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