HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
FDA premarket approval P840062/S007 · decided 2000-12-07
Approval details
- PMA number
- P840062
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2000-08-18
- Decision date
- 2000-12-07
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR AN ADDITIONAL TRADE NAME FOR COLLACOTE, COLLATAPE AND COLLAPLUG. THESE DEVICES WILL ALSO BE KNOWN AS HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY. THE SIZES OF THE WOUND DRESSINGS WILL BE IDENTICAL TO THE THREE COLLACOTE PRODUCTS. THERE WILL BE NO CHANGES IN THE DEVICE EXCEPT THE USE OF AN ADDITIONAL NEW TRADE MANE.
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