PMA P960042S027
- Device
- SPECTRANETICS LASER CATHETERS SLS II LASER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S027
- Product code
- MFA
- Decision date
- 2011-07-14
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER CATHETERS SLS II LASER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S027
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2011-07-14
- Decision code
- APPR
- Date received
- 2011-02-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING.