SPECTRANETICS LASER SHEATHS
FDA premarket approval P960042/S054 · decided 2016-06-16
Approval details
- PMA number
- P960042
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANETICS LASER SHEATHS
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2016-05-25
- Decision date
- 2016-06-16
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Addition of a manufacturing tool used in the fiber trimming process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.