PMA P960042S003
- Device
- 14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S003
- Decision date
- 1999-02-08
- Approval order statement
- Approval for separately packaged 12 French Outer Sheaths.
Current openFDA PMA Record#
- Device
- 14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S003
- Decision date
- 1999-02-08
- Decision code
- APPR
- Date received
- 1998-08-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for separately packaged 12 French Outer Sheaths.