DISCOVERY
FDA premarket approval P940031/S042 · decided 2005-09-13
Approval details
- PMA number
- P940031
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Trade name
- DISCOVERY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-15
- Decision date
- 2005-09-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF AN INLINE TEMPERATURE AND HUMIDITY CONTROLLED CURE TUNNEL TO FILL CHANNELS.
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