ENDOTAK RELIANCE IS-I PASSIVE FIXATION
FDA premarket approval P910073/S091 · decided 2012-01-05
Approval details
- PMA number
- P910073
- Supplement
- S091
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK RELIANCE IS-I PASSIVE FIXATION
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2010-12-14
- Decision date
- 2012-01-05
- Days to decision
- 387 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DRUG MATERIAL AND SUPPLIER CHANGES AS WELL AS DISTAL TIP DESIGN CHANGES.
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