FLEXTEND LEADS
FDA premarket approval P960006/S032 · decided 2012-02-29
Approval details
- PMA number
- P960006
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Trade name
- FLEXTEND LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2012-01-24
- Decision date
- 2012-02-29
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
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