FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS
FDA premarket approval P960004/S072 · decided 2015-08-18
Approval details
- PMA number
- P960004
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2015-07-21
- Decision date
- 2015-08-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- REMOVE CIRCULAR TOOLS FROM USE IN THE MANUFACTURING OF FINELINE II PACING LEADS.
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