PMA P960042S007
- Device
- 16F LASER SHEATH ENHANCEMENT MODEL#500-013
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S007
- Product code
- MFA
- Decision date
- 2002-01-25
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE 16F LASER SHEATH KIT.
Current openFDA PMA Record#
- Device
- 16F LASER SHEATH ENHANCEMENT MODEL#500-013
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S007
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2002-01-25
- Decision code
- APPR
- Date received
- 2001-07-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE 16F LASER SHEATH KIT.