PMA P010012S375
- Device
- EASY TRAK 2 FAMILY
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S375
- Product code
- NVN
- Decision date
- 2014-10-22
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- UPDATE THE PROXIMAL ELECTRODE LASER WELDING PARAMETERS FOR WELDING THE PROXIMAL ELECTRODE TO THE LEAD COIL.
Current openFDA PMA Record#
- Device
- EASY TRAK 2 FAMILY
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S375
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2014-10-22
- Decision code
- OK30
- Date received
- 2014-10-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE THE PROXIMAL ELECTRODE LASER WELDING PARAMETERS FOR WELDING THE PROXIMAL ELECTRODE TO THE LEAD COIL.