PMA P960004S087
- Device
- Fineline II Lead Family
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S087
- Product code
- NVN
- Decision date
- 2019-01-10
- 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
- Change the authorized laboratory for testing USP grade polyethylene glycol (PEG) 3350 and mannitol material to other service providers.
Current openFDA PMA Record#
- Device
- Fineline II Lead Family
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S087
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-01-10
- Decision code
- OK30
- Date received
- 2018-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the authorized laboratory for testing USP grade polyethylene glycol (PEG) 3350 and mannitol material to other service providers.