Fineline II Lead Family
FDA premarket approval P960004/S087 · decided 2019-01-10
Approval details
- PMA number
- P960004
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Fineline II Lead Family
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2018-12-20
- Decision date
- 2019-01-10
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change the authorized laboratory for testing USP grade polyethylene glycol (PEG) 3350 and mannitol material to other service providers.
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