PMA P960006S049
- Device
- Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S049
- Product code
- NVN
- Decision date
- 2019-04-08
- 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
- Modifications to the frequency, equipment and method for monitoring airborne particulates.
Current openFDA PMA Record#
- Device
- Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S049
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-04-08
- Decision code
- OK30
- Date received
- 2019-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.