PMA P960042S004
- Device
- SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S004
- Decision date
- 1999-08-03
- Approval order statement
- Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S004
- Decision date
- 1999-08-03
- Decision code
- APPR
- Date received
- 1999-02-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits.