PMA P960042S008
- Device
- SPECTRANETICS LASER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S008
- Product code
- MFA
- Decision date
- 2002-05-02
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE 12F AND 14F LASER SHEATH KITS (MODELS 500-001 AND 500-012).
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S008
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2002-05-02
- Decision code
- APPR
- Date received
- 2002-01-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE 12F AND 14F LASER SHEATH KITS (MODELS 500-001 AND 500-012).