TRANSVENOUS BIPOLAR PACING LEAD
FDA premarket approval P960006/S029 · decided 2011-05-19
Approval details
- PMA number
- P960006
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRANSVENOUS BIPOLAR PACING LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2010-12-01
- Decision date
- 2011-05-19
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A CHANGE TO LASER WELDING EQUIPMENT USED IN THE MANUFACTURE OF PACING LEADS.
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