SPECTRANETICS LASER SHEATHS (SLS)
FDA premarket approval P960042/S005 · decided 2000-03-17
Approval details
- PMA number
- P960042
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANETICS LASER SHEATHS (SLS)
- Applicant
- Spectranetics (Philips)
- Date received
- 1999-09-28
- Decision date
- 2000-03-17
- Days to decision
- 171 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.