PMA P960042S043
- Device
- SPECTRANETICS LASER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S043
- Product code
- MFA
- Decision date
- 2013-06-14
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR A MATERIAL CHANGE TO THE INNER LINER OF THE DEVICES.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S043
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2013-06-14
- Decision code
- APPR
- Date received
- 2012-11-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MATERIAL CHANGE TO THE INNER LINER OF THE DEVICES.