DISCOVERY
FDA premarket approval P940031/S044 · decided 2006-06-28
Approval details
- PMA number
- P940031
- Supplement
- S044
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISCOVERY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-29
- Decision date
- 2006-06-28
- Days to decision
- 303 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF INSPECTION CRITERIA TO ALLOW FOR SOLDER BALLS UNDER COMPONENTS ON THE HYBRID.
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